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This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.
This was a 12-week randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, multi-center study to assess the efficacy of ESN364 in postmenopausal women suffering from vasomotor symptoms (hot flashes).
This study consisted of a screening period (Days -35 to -1, including the screening visit [Visit 1] and a minimum 7-day collection of baseline vasomotor symptom frequency and severity assessments), a 12 week treatment period (Day 1 [Visit 2] to Week 12 [Visit 5]), and a follow up visit (Week 15 [Visit 6]) 3 weeks after the last dose of study drug.
The study was performed on an ambulatory basis. The screening visit (Visit 1) occurred up to 35 days prior to randomization. Eligibility was assessed via physical examination, clinical laboratory testing, vital signs, ECG, Pap smear, mammography, and endometrial biopsy. Subjects received an electronic diary to record daily vasomotor symptoms during the duration of the screening period. Subjects who had ≥7 consecutive days of vasomotor symptom recordings participated in the study. Subjects are encouraged to continue recording for the duration of the whole screening period. The electronic diary was reviewed by study site staff on Day 1 (Visit 2) to confirm study eligibility. Subjects were rescreened 1 time upon approval of the medical monitor.
During the treatment period, subjects returned to the study site every 4 weeks for assessments.
The follow-up visit occurred approximately 3 weeks following the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. |
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| Fezolinetant 15 mg | Experimental | Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. |
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| Fezolinetant 30 mg | Experimental | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
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| Fezolinetant 60 mg | Experimental | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
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| Fezolinetant 90 mg | Experimental | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
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| Fezolinetant 30 mg + Placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fezolinetant | Drug | Oral Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Baseline and week 4 |
| Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Baseline and week 12 |
| Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4 | Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anniston | Alabama | 36207 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32102086 | Derived | Fraser GL, Lederman S, Waldbaum A, Kroll R, Santoro N, Lee M, Skillern L, Ramael S. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020 Apr;27(4):382-392. doi: 10.1097/GME.0000000000001510. |
| Label | URL |
|---|---|
| Link to plain language summary of the study on the Trial Results Summaries website. | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Prior to randomization, participants had a screening period during which a minimum 7-day collection of baseline VMS frequency and severity assessments were performed.
Postmenopausal women participants 40 to 65 years of age who had at least 50 moderate to severe vasomotor symptoms (VMS) per week and who met the inclusion criteria and none of the exclusion criteria were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo BID | Participants received fezolinetant matching placebo capsules orally, twice daily (BID) for a period of 12 weeks. |
| FG001 | Fezolinetant 15 mg BID | Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2018 | Sep 1, 2021 |
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Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
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| Fezolinetant 60 mg + Placebo | Experimental | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
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| Fezolinetant 120 mg + Placebo | Experimental | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
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| Placebo | Drug | Oral Capsule |
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| Baseline and week 4 |
| Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12 | Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher scores indicates greater severity. | Baseline and week 12 |
| Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15 |
| Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week | Severity of mild, moderate & severe VMS per day was calculated as follows [(number of mild VMS × 1) + (number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily mild/moderate/severe VMS Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot & was sweating & needed to take action Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity. | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week | Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for patients that had no moderate or severe VMS. Higher score indicates greater severity. | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15 |
| Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week | The hot flash score per 24h (or 12 h day time or 12 h night time) of VMS (mild, moderate, and severe) is calculated as follows: (number of mild VMS x 1) + (number of moderate VMS x 2) + (number of severe VMS x 3). Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Higher score indicates greater severity. | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week | The hot flash score per 24h of moderate and severe VMS is calculated as follows: (number of moderate VMS x 2) + (number of severe VMS x 3). Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). VMS. Baseline is the average frequency of 24h vasomotor symptom from 7 non-missing days prior to Day 1. Higher score indicates greater severity. | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 |
| Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Change From Baseline in Hot Flash-Related Daily Interference Scale (HFRDIS) at Weeks 4, 8, 12, and 15 | The HFRDIS is a 10-item scale that measures a woman's perceptions of the degree to which VMS interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, and enjoying life); the tenth item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory, which assess the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which VMS had interfered with each item during the previous 2-week time interval using a 0 (do not interfere) to 10 (completely interfere) scale. Overall mean score is the average of individual item scores (sum of items/10). | Baseline and weeks 4, 8, 12, and 15 |
| Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15 | The LSEQ is a 10-item self-rated questionnaire that assesses a participants aspects of sleep and early morning behavior. The questions are grouped into 4 chronological areas: ease of getting to sleep, perceived quality of sleep, ease of awaking from sleep, and integrity of early morning behavior following wakefulness. The LSEQ is a visual analog scale that requires respondents to place marks on a group of 10 cm lines. Lines extend between extremes like "more difficult than usual" and "easier than usual." Responses are measured using a 100 mm scale and are averaged to a score for each domain. Higher scores indicates better sleep and better early morning behavior. | Weeks 4, 8, 12, and 15 |
| Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15 | The GCS is a 21-item scale that provides a brief but comprehensive and valid measure of climacteric symptomatology. Each item is rated by the participant according to its severity using a 4-point rating scale from 0 (none) to 3 (severe). The first 20 items of the scale combine into 3 main independent symptom measures by summing up the individual item scores: psychological symptoms (items 1 to 11; score 0 to 33), physical symptoms (items 12 to 18; score 0 to 21), and VMS (items 19 to 20; score 0 to 6). Item 21 is a probe for sexual dysfunction. The total score can range from 0 to 63. Higher scores indicate worse symptoms. | Baseline and weeks 4, 8, 12, and 15 |
| Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15 | The MENQoL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of 1 of 4 domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26), and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a 0 (not bothersome) to 6 (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a "1" and endorsement a "2," plus the number of the particular rating, so that the possible score on any item ranges from 1 to 8. Higher scores indicate that menopause symptoms are more bothersome. | Baseline and weeks 4, 8, 12, and 15 |
| Change Over Time From Baseline in Plasma Concentrations of Luteinizing Hormone (LH) at Week 12 | Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. | Baseline and week 12 |
| Change Over Time From Baseline in Plasma Concentrations of Follicle-Stimulating Hormone (FSH) at Week 12 | Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. | Baseline and week 12 |
| Change Over Time From Baseline in Plasma Concentrations of Estradiol (E2) at Week 12 | Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. The analysis value for Estradiol was imputed as 73.4/2 = 36.7 when result was < 73.4. | Baseline and week 12 |
| Change Over Time From Baseline in Plasma Concentrations of Sex Hormone-Binding Globulin (SHBG) at Week 12 | Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. | Baseline and week 12 |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| Research Site | Phoenix | Arizona | 85023 | United States |
| Research Site | Los Angeles | California | 90057 | United States |
| Research Site | Oceanside | California | 92056 | United States |
| Research Site | Panorama City | California | 91402 | United States |
| Research Site 052 | Sacramento | California | 95821 | United States |
| Research Site 058 | Sacramento | California | 95821 | United States |
| Research Site | San Diego | California | 92114 | United States |
| Research Site | Thousand Oaks | California | 91360 | United States |
| Research Site | Valley Village | California | 91607 | United States |
| Research Site | Denver | Colorado | 80209 | United States |
| Research Site | Milford | Connecticut | 06460 | United States |
| Research Site | Crystal River | Florida | 34429 | United States |
| Research Site | DeLand | Florida | 32720 | United States |
| Research Site | Jupiter | Florida | 33458 | United States |
| Research Site | Lake Worth | Florida | 33461 | United States |
| Research Site | Miami | Florida | 33144 | United States |
| Research Site | Ormond Beach | Florida | 32174 | United States |
| Research Site | Port Saint Lucie | Florida | 34952 | United States |
| Research Site | Atlanta | Georgia | 30312 | United States |
| Research Site | Norcross | Georgia | 30092 | United States |
| Research Site | Meridian | Idaho | 83642 | United States |
| Research Site | Champaign | Illinois | 61820 | United States |
| Research Site | Marrero | Louisiana | 70072 | United States |
| Research Site | Elkridge | Maryland | 21075 | United States |
| Research Site | Watertown | Massachusetts | 02472 | United States |
| Research Site | Lincoln | Nebraska | 68510 | United States |
| Research Site | Norfolk | Nebraska | 68701 | United States |
| Research Site | Las Vegas | Nevada | 89123 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | Williamsville | New York | 14221 | United States |
| Research Site | Cincinnati | Ohio | 45267 | United States |
| Research Site | Cleveland | Ohio | 44122 | United States |
| Research Site | Columbus | Ohio | 43210 | United States |
| Research Site | Columbus | Ohio | 43213 | United States |
| Research Site | Oklahoma City | Oklahoma | 73112 | United States |
| Research Site | Philadelphia | Pennsylvania | 19140 | United States |
| Research Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Site | Clarksville | Tennessee | 37040 | United States |
| Research Site | Kingsport | Tennessee | 37660 | United States |
| Research Site | Houston | Texas | 77058 | United States |
| Research Site | Hurst | Texas | 76054 | United States |
| Research Site | Lampasas | Texas | 76550 | United States |
| Research Site | Plano | Texas | 75093 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Riverton | Utah | 84065 | United States |
| Research Site | Charlottesville | Virginia | 22911 | United States |
| Research Site | Vienna | Virginia | 22182 | United States |
| Research Site | Seattle | Washington | 98105 | United States |
| Research Site | Spokane | Washington | 99207 | United States |
| FG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| FG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| FG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| FG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, once daily (QD) and matching placebo QD for a period of 12 weeks. |
| FG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| FG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
|
The safety analysis set (SAF) consisted of all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo BID | Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. |
| BG001 | Fezolinetant 15 mg BID | Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. |
| BG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| BG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| BG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| BG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| BG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| BG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Frequency of Moderate and Severe Vasomotor Symptoms per 24h | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. Baseline was the average frequency of 24 h vasomotor symptom from 7 non-missing days prior to day 1. | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation. | Mean | Standard Deviation | VMS per day |
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| Severity of Moderate and Severe Vasomotor Symptoms per 24h | Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Higher score indicates greater severity. Baseline was the average severity of 24h vasomotor symptom from 7 non-missing days prior to Day 1. | FAS Population | Mean | Standard Deviation | Score on a scale |
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| Frequency of Mild, Moderate, and Severe Vasomotor Symptoms per 24h | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. Baseline was the average frequency of 24 h vasomotor symptom from 7 non-missing days prior to day 1. | FAS Population | Mean | Standard Deviation | VMS per day |
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| Severity of Mild, Moderate, and Severe Vasomotor Symptoms per 24h | Severity of mild, moderate and severe VMS per day was calculated as follows: [(number of mild VMS × 1) + (number of moderate VMS × 2) + (number of severe VMS × 3)]/ number of daily mild/moderate/severe VMS. Higher score indicates greater severity. Baseline was the average severity of 24h vasomotor symptom from 7 non-missing days prior to Day 1. | FAS Population | Mean | Standard Deviation | Score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | VMS per day | Baseline and week 4 |
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| Primary | Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | VMS per day | Baseline and week 12 |
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| Primary | Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4 | Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity. | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and week 4 |
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| Primary | Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12 | Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher scores indicates greater severity. | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and week 12 |
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| Secondary | Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | VMS per day | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | VMS per day | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15 |
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| Secondary | Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week | Severity of mild, moderate & severe VMS per day was calculated as follows [(number of mild VMS × 1) + (number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily mild/moderate/severe VMS Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot & was sweating & needed to take action Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity. | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week | Severity of moderate to severe VMS per day was calculated as follows: [(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for patients that had no moderate or severe VMS. Higher score indicates greater severity. | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15 |
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| Secondary | Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week | The hot flash score per 24h (or 12 h day time or 12 h night time) of VMS (mild, moderate, and severe) is calculated as follows: (number of mild VMS x 1) + (number of moderate VMS x 2) + (number of severe VMS x 3). Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Higher score indicates greater severity. | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week | The hot flash score per 24h of moderate and severe VMS is calculated as follows: (number of moderate VMS x 2) + (number of severe VMS x 3). Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). VMS. Baseline is the average frequency of 24h vasomotor symptom from 7 non-missing days prior to Day 1. Higher score indicates greater severity. | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Percent Reduction | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Percent Reduction | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 |
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| Secondary | Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). | FAS population with available data at specified time point. | Posted | Number | participants | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Change From Baseline in Hot Flash-Related Daily Interference Scale (HFRDIS) at Weeks 4, 8, 12, and 15 | The HFRDIS is a 10-item scale that measures a woman's perceptions of the degree to which VMS interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, and enjoying life); the tenth item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory, which assess the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which VMS had interfered with each item during the previous 2-week time interval using a 0 (do not interfere) to 10 (completely interfere) scale. Overall mean score is the average of individual item scores (sum of items/10). | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and weeks 4, 8, 12, and 15 |
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| Secondary | Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15 | The LSEQ is a 10-item self-rated questionnaire that assesses a participants aspects of sleep and early morning behavior. The questions are grouped into 4 chronological areas: ease of getting to sleep, perceived quality of sleep, ease of awaking from sleep, and integrity of early morning behavior following wakefulness. The LSEQ is a visual analog scale that requires respondents to place marks on a group of 10 cm lines. Lines extend between extremes like "more difficult than usual" and "easier than usual." Responses are measured using a 100 mm scale and are averaged to a score for each domain. Higher scores indicates better sleep and better early morning behavior. | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Weeks 4, 8, 12, and 15 |
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| Secondary | Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15 | The GCS is a 21-item scale that provides a brief but comprehensive and valid measure of climacteric symptomatology. Each item is rated by the participant according to its severity using a 4-point rating scale from 0 (none) to 3 (severe). The first 20 items of the scale combine into 3 main independent symptom measures by summing up the individual item scores: psychological symptoms (items 1 to 11; score 0 to 33), physical symptoms (items 12 to 18; score 0 to 21), and VMS (items 19 to 20; score 0 to 6). Item 21 is a probe for sexual dysfunction. The total score can range from 0 to 63. Higher scores indicate worse symptoms. | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and weeks 4, 8, 12, and 15 |
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| Secondary | Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15 | The MENQoL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of 1 of 4 domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26), and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a 0 (not bothersome) to 6 (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a "1" and endorsement a "2," plus the number of the particular rating, so that the possible score on any item ranges from 1 to 8. Higher scores indicate that menopause symptoms are more bothersome. | FAS population with available data at specified time point. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and weeks 4, 8, 12, and 15 |
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| Secondary | Change Over Time From Baseline in Plasma Concentrations of Luteinizing Hormone (LH) at Week 12 | Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. | FAS population with available data at baseline and specified time point. | Posted | Mean | Standard Deviation | International unit per liter (IU/L) | Baseline and week 12 |
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| Secondary | Change Over Time From Baseline in Plasma Concentrations of Follicle-Stimulating Hormone (FSH) at Week 12 | Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. | FAS population with available data at baseline and specified time point. | Posted | Mean | Standard Deviation | IU/L | Baseline and week 12 |
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| Secondary | Change Over Time From Baseline in Plasma Concentrations of Estradiol (E2) at Week 12 | Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. The analysis value for Estradiol was imputed as 73.4/2 = 36.7 when result was < 73.4. | FAS population with available data at baseline and specified time point. | Posted | Mean | Standard Deviation | picomole per milliliter (pmol/L) | Baseline and week 12 |
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| Secondary | Change Over Time From Baseline in Plasma Concentrations of Sex Hormone-Binding Globulin (SHBG) at Week 12 | Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. | FAS population with available data at baseline and specified time point. | Posted | Mean | Standard Deviation | Nanomole per liter (nmol/L) | Baseline and week 12 |
|
From date of informed consent until end of the study (up to 15 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo BID | Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks. | 0 | 43 | 0 | 43 | 5 | 43 |
| EG001 | Fezolinetant 15 mg BID | Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks. | 0 | 45 | 0 | 45 | 9 | 45 |
| EG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. | 0 | 43 | 0 | 43 | 7 | 43 |
| EG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. | 0 | 45 | 0 | 45 | 11 | 45 |
| EG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. | 0 | 44 | 0 | 44 | 11 | 44 |
| EG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. | 0 | 43 | 0 | 43 | 12 | 43 |
| EG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. | 0 | 45 | 1 | 45 | 14 | 45 |
| EG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. | 0 | 44 | 0 | 44 | 11 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v20.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v20.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v20.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v20.0 | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Astellas Pharma Global Development, Inc. | 800-888-7704 | astellas.resultsdisclosure@astellas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2018 | Sep 1, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608808 | fezolinetant |
Not provided
Not provided
Not provided
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| ANCOVA |
| 0.0004 |
LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates. |
| LSMean difference |
| -3.0 |
| Standard Error of the Mean |
| 0.84 |
| 2-Sided |
| 95 |
| -4.68 |
| -1.38 |
| Superiority |
| ANCOVA | 0.0010 | LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates. | LSMean difference | -2.8 | Standard Error of the Mean | 0.84 | 2-Sided | 95 | -4.44 | -1.14 | Superiority |
| ANCOVA | <0.0001 | LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates. | LSMean difference | -3.5 | Standard Error of the Mean | 0.84 | 2-Sided | 95 | -5.20 | -1.89 | Superiority |
| ANCOVA | 0.0058 | LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates. | LSMean difference | -2.3 | Standard Error of the Mean | 0.84 | 95 | -4.00 | -0.68 | Superiority |
| ANCOVA | 0.0003 | LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates. | LSMean difference | -3.0 | Standard Error of the Mean | 0.82 | 2-Sided | 95 | -4.65 | -1.41 | Superiority |
| ANCOVA | 0.0042 | LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates. | LSMean difference | -2.4 | Standard Error of the Mean | 0.84 | 2-Sided | 95 | -4.06 | 0.76 | Superiority |
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
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|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| Fezolinetant 30 mg BID |
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| Fezolinetant 30 mg BID |
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG002 | Fezolinetant 30 mg BID | Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| Fezolinetant 30 mg BID |
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks. |
| OG003 | Fezolinetant 60 mg BID | Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks. |
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
|
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
|
|
| OG004 | Fezolinetant 90 mg BID | Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks. |
| OG005 | Fezolinetant 30 mg QD | Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG006 | Fezolinetant 60 mg QD | Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
| OG007 | Fezolinetant 120 mg QD | Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks. |
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