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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43AG056209-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to assess the efficacy and safety of repeated administration of G-CSF for the treatment of hot flashes and vasomotor symptoms in women with naturally-occurring or surgically induced menopause. G-CSF will be administered three times at 28 day intervals to postmenopausal women, ages 40 to 65, suffering at least 49 moderate to severe hot flashes per week.
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled study. Eligible subjects will be stratified by natural or surgical menopause and randomized (1:1) to receive 3 single injections, 28-days apart, of either G-CSF or placebo.
This study will consist of a 14-21 day screening period. Subjects enrolled will be given three single 1.0 mL subcutaneous (SC) injections (repeated 28-days apart), in the outer area of either upper arm, of either G-CSF or placebo (sterile physiological saline) at Baseline, Day 28 and Day 56. Subjects will be followed for 12 weeks and will complete hot flash diary entries every day for the duration of treatment. Safety will be assessed by adverse events, clinical laboratory tests (clinical chemistry and complete blood count with differential) and vital signs. A follow-up phone call will occur 60 days after the last dose of study drug.
Eligibility will be assessed via physical examination, clinical laboratory testing, vital signs.
Subjects will receive a diary in which to record daily hot flashes symptoms during the duration of the screening period. Subjects must have at least 14 days of hot flash recordings to participate in the study. The diary will be reviewed by study site staff on Baseline (Day 0) to confirm study eligibility.
During the treatment period, subjects will return to the study site at Days 1, 21, 28, 29, 49, 56, 57, and 84 for assessments.
The follow-up phone call will occur approximately 60 days following the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: G-CSF | Active Comparator | Intervention: G-CSF given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Filgrastim |
|
| Comparator: Placebo/Saline | Placebo Comparator | Intervention: Placebo/saline given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF | Biological | G-CSF injected subcutaneously 3 times (Days 0, 28, 56) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence, including the exacerbation of a pre-existing condition, in a subject or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. This includes any experience that results in death; is acutely life-threatening; requires inpatient hospitalization or prolongs the existing hospitalization; results in persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; is a congenital anomaly/birth defect; or requires medical or surgical intervention to prevent one of the outcomes listed above. | From first dose date up to 30 days after last dose (up to 16 weeks) |
| Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0 | Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 0. Blood samples were collected 24 hours after adminstration of G-CSF on day 0. | Baseline and day 1 |
| Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28 | Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 28. Blood samples were collected 24 hours after adminstration of G-CSF on day 28. | Baseline and day 29 |
| Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56. | Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 56. Blood samples were collected 24 hours after adminstration of G-CSF on day 56. | Baseline and day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard C Duke, PhD | MenoGeniX, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 2 | Aurora | Colorado | 80045 | United States | ||
| Site 1 |
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Prior to randomization, participants had a screening period during which a minimum 7-day collection of baseline hot flash frequency and severity assessments were performed.
Postmenopausal women participants 40 to 65 years of age who had moderate to severe vasomotor symptoms (VMS) and seeking treatment or relief for hot flashes associated with menopause, confirmed as menopausal, had to have 7 to 8 moderate to severe hot flashes per day within the 7 days prior to randomization and who met the inclusion criteria and none of the exclusion criteria were enrolled in this study. A total of 61 subjects were randomized to receive G-CSF or saline in this trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: G-CSF (All Subjects) | Intervention: G-CSF (300 mcg/injection as filgrastim) given by subcutaneous injection on days 0, 28 and 56. This group is all women in the study that received G-CSF. |
| FG001 | Comparator: Placebo/Saline (All Subjects) | Intervention: Placebo (as saline) given by subcutaneous injection on days 0, 28 and 56. This group is all women in the study that received placebo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: G-CSF (All Subjects) | Intervention: G-CSF given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Filgrastim G-CSF: G-CSF injected subcutaneously 3 times (Days 0, 28, 56) |
| BG001 | Comparator: Placebo/Saline (All Subjects) |
| 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 | All randomized participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence, including the exacerbation of a pre-existing condition, in a subject or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. This includes any experience that results in death; is acutely life-threatening; requires inpatient hospitalization or prolongs the existing hospitalization; results in persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; is a congenital anomaly/birth defect; or requires medical or surgical intervention to prevent one of the outcomes listed above. | Posted | Number | Participants | From first dose date up to 30 days after last dose (up to 16 weeks) |
|
From first dose date up to 30 days after last dose (up to 16 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: G-CSF (All Subjects) | Intervention: G-CSF (300 mcg/injection as filgrastim) given by subcutaneous injection on days 0, 28 and 56. This group is all women in the study that received G-CSF. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Duke | MenoGeniX | 303-995-7979 | debra.duke@menogenix.com |
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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 | Oct 12, 2020 | May 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2022 | May 9, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Placebo/Saline | Other | Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56) |
|
|
| Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo) |
Change from baseline in white blood cell counts on day 84. Blood samples were collected 24 hours after adminstration of G-CSF on day 84. |
| Baseline and day 84 |
| Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Baseline and week 4 |
| Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Baseline and week 12 |
| Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4 | CDS (Composite Daily Hot Flash Severity) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Baseline and week 4 |
| Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12 | CDS (Composite Daily Hot Flash Severity) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Baseline and week 12 |
| Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4 | HFSS (Daily Hot Flash Severity Score) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Baseline and week 4 |
| Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12 | HFSS (Daily Hot Flash Severity Score) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Baseline and week 12 |
| Weeks 1-12 |
| Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | CDS was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Weeks 1-12 |
| Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | HFSS was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. HFSS = ((number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3))/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe (S) hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity. | Weeks 1-12 |
| Percent Change in M+S at 12 Weeks in Demographic Subgroups | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Baseline and Week 12 |
| Net Change in HFSS at 12 Weeks in Demographic Subgroups | HFSS (Daily Hot Flash Severity Score) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. HFSS = ((number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3))/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe (S) hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received | Baseline and Week 12 |
| Net Change in MENQOL VMS Score | Menopause-specific Quality of Life (MENQOL) Questionnaire. The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). MENQOL VMS refers to the answers to items 1-3 where 6 = most bothersome and 0 = least bothersome). (Maximum bothersomeness = 18; No bothersomeness = 0) | Baseline and week 12 |
| Net Change in HFRDIS Score | The Hot Flash Related Daily Interference Scale (HFRDIS) measures (as a score of 0 to 10) the effect of hot flashes on overall quality of life and on nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life. The 10 answers are added up to get a total score. HFRDIS Score (Maximum Bothersomness = 100; No Bothersomeness = 0). The higher the score, the more bothersome the symptoms. | Baseline and week 12 |
| Net Change in ISI Score at 12 Weeks | The Insomnia Severity Index has seven questions. For each question, most bothersome = 4; not bothersome = 0. The seven answers are added up to get a total score. Total score categories: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia; 15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe) | Baseline and week 12 |
| Net Change in FSS Score at 12 Weeks | Fatigue Severity Scale (FSS) of Sleep Disorders. The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. The FSS is a short questionnaire (10 questions) that requires the subject to rate level of fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. Each statement is read and the corresponding number from 1 to 7 is circled. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. (Maximum bother = 70; No bother = 0) | Baseline and week 12 |
| Denver |
| Colorado |
| 80209 |
| United States |
Intervention: Placebo/saline given by subcutaneous injection repeated 3 times (Days 0, 28, 56) Other name: Saline Placebo/Saline: Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56) |
| BG002 | Total | Total of all reporting groups |
| 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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| Daily Moderate + Severe Hot Flashes (M+S) | Average number of daily moderate (M) and severe (S) hot flashes (M+S) during the seven days prior to randomization to receive G-CSF or placebo.A daily frequency per week was derived by taking the mean of the data over 7 days. | Mean | Standard Deviation | Number of hot flashes per day |
|
| Composite Daily Hot Flash Severity (CDS) | CDS = (number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3) during the seven days preceding randomization. A daily frequency per week was derived by taking the mean of the data over 7 days. | Mean | Standard Deviation | Number of hot flashes per day |
|
| Hot Flash Severity Score (HFSS) | HFSS = ((number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3))/daily total hot flashes) during the seven days preceding randomization, where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes during the seven days prior to randomization. A daily frequency per week was derived by taking the mean of the data over 7 days. | Mean | Standard Deviation | Score on a scale |
|
| White Blood Cell Counts (WBC) | Blood samples were obtained on day 0 upon randomization and first administration of G-CSF or placebo. | Mean | Standard Deviation | White Blood Cells per mL |
|
| Menopause-specific Quality of Life Questionnaire - Vasomotor symptom (MENQOL VMS) Score | Menopause-specific Quality of Life (MENQOL) Questionnaire. The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). MENQOL VMS refers to the answers to items 1-3 where 6 = most bothersome and 0 = least bothersome). (Maximum bother = 18; No bother = 0) | Mean | Standard Deviation | Score on a scale |
|
| Hot Flash Related Daily Interference Scale (HFRDIS) Score | The Hot Flash Related Daily Interference Scale (HFRDIS) measures (as a score of 0 to 10) the effect of hot flashes on overall quality of life and on nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life. The 10 answers are added up to get a total score.HFRDIS Score (Maximum Bother = 100; No Bother = 0). The higher the score, the more bothersome the symptoms. | Mean | Standard Deviation | Score on a scale |
|
| Insomnia Severity Index (ISI) Score | The Insomnia Severity Index has seven questions.For each question, most bothersome = 4; not botherrsome = 0. The seven answers are added up to get a total score. Total score categories: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia; 15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe) | Mean | Standard Deviation | Score on a scale |
|
| Fatigue Severity Scale (FSS) Score | Fatigue Severity Scale (FSS) of Sleep Disorders. The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. The FSS is a short questionnaire that requires the subject to rate level of fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms.Each statement is read and the corresponding number from 1 to 7 is circled. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. (Maximum bother = 70; No bother = 0) | Mean | Standard Deviation | Score on a scale |
|
Intervention: G-CSF (300 mcg/injection as filgrastim) given by subcutaneous injection on days 0, 28 and 56. This group is all women in the study that received G-CSF.
| OG001 | Comparator: Placebo/Saline (All Subjects) | Intervention: Placebo (as saline) given by subcutaneous injection on days 0, 28 and 56. This group is all women in the study that received placebo. |
| OG002 | Experimental: G-CSF (White, NH Subgroup) | Intervention: G-CSF (300 mcg/injection as filgrastim) given by subcutaneous injection on days 0, 28 and 56. This is a subgroup of the women in the study that received G-CSF and that self-identified as white, non-Hispanic. |
| OG003 | Comparator: Placebo/Saline (White, NH Subgroup) | Intervention: Placebo (as saline) given by subcutaneous injection on days 0, 28 and 56. This is a subgroup of the women in the study that received placebo and that self-identified as white, non-Hispanic. |
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| Primary | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0 | Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 0. Blood samples were collected 24 hours after adminstration of G-CSF on day 0. | Posted | Mean | Standard Error | Number of white blood cells per mL | Baseline and day 1 |
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| Primary | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28 | Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 28. Blood samples were collected 24 hours after adminstration of G-CSF on day 28. | Posted | Mean | Standard Error | Number of white blood cells per mL | Baseline and day 29 |
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| Primary | Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56. | Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 56. Blood samples were collected 24 hours after adminstration of G-CSF on day 56. | Posted | Mean | Standard Error | Number of white blood cells per mL | Baseline and day 57 |
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| Primary | Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo) | Change from baseline in white blood cell counts on day 84. Blood samples were collected 24 hours after adminstration of G-CSF on day 84. | Posted | Mean | Standard Error | Number of white blood cells per mL | Baseline and day 84 |
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| Primary | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Least Squares Mean | 95% Confidence Interval | Number of hot flashes per day | Baseline and week 4 |
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| Primary | Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Posted | Least Squares Mean | 95% Confidence Interval | Number of hot flashes per day | Baseline and week 12 |
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| Primary | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4 | CDS (Composite Daily Hot Flash Severity) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Least Squares Mean | 95% Confidence Interval | Number of hot flashes per day | Baseline and week 4 |
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| Primary | Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12 | CDS (Composite Daily Hot Flash Severity) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Least Squares Mean | 95% Confidence Interval | Number of hot flashes per day | Baseline and week 12 |
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| Primary | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4 | HFSS (Daily Hot Flash Severity Score) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Least Squares Mean | 95% Confidence Interval | Hot flash severity score | Baseline and week 4 |
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| Primary | Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12 | HFSS (Daily Hot Flash Severity Score) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Least Squares Mean | 95% Confidence Interval | Hot flash severity score | Baseline and week 12 |
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| Secondary | Number of Subjects Achieving >50% Reduction in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes up to Week 12 | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. Outcome Measure Data Table * Measure Type: Least Squares Mean * Measure ofDispersion | Posted | Number | Number of subjects | Weeks 1-12 |
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| Secondary | Number of Subjects Acheiving >50% Reduction in the Mean Composite Daily Hot Flash Severity (CDS) up to Week 12 | CDS was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Number | Number of subjects | Weeks 1-12 |
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| Secondary | Number of Subjects Acheiving >0.30 Reduction in the Mean Daily Hot Flash Severity Score (HFSS) up to Week 12 | HFSS was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. HFSS = ((number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3))/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe (S) hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Number | Number of subjects | Weeks 1-12 |
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| Secondary | Percent Change in M+S at 12 Weeks in Demographic Subgroups | The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Mean | Standard Error | Percent change in hot flashes | Baseline and Week 12 |
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| Secondary | Net Change in HFSS at 12 Weeks in Demographic Subgroups | HFSS (Daily Hot Flash Severity Score) was calculated as follows: [(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)]. HFSS = ((number of daily mild hot flashes x1) + (number of daily moderate hot flashes x2) + (number of severe hot flashes x3))/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe (S) hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Mean | Standard Error | Hot flash severity score | Baseline and Week 12 |
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| Secondary | Net Change in MENQOL VMS Score | Menopause-specific Quality of Life (MENQOL) Questionnaire. The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). MENQOL VMS refers to the answers to items 1-3 where 6 = most bothersome and 0 = least bothersome). (Maximum bothersomeness = 18; No bothersomeness = 0) | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Mean | Standard Error | Score on a scale | Baseline and week 12 |
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| Secondary | Net Change in HFRDIS Score | The Hot Flash Related Daily Interference Scale (HFRDIS) measures (as a score of 0 to 10) the effect of hot flashes on overall quality of life and on nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life. The 10 answers are added up to get a total score. HFRDIS Score (Maximum Bothersomness = 100; No Bothersomeness = 0). The higher the score, the more bothersome the symptoms. | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Mean | Standard Error | score on a scale | Baseline and week 12 |
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| Secondary | Net Change in ISI Score at 12 Weeks | The Insomnia Severity Index has seven questions. For each question, most bothersome = 4; not bothersome = 0. The seven answers are added up to get a total score. Total score categories: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia; 15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe) | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Mean | Standard Error | score on a scale | Baseline and week 12 |
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| Secondary | Net Change in FSS Score at 12 Weeks | Fatigue Severity Scale (FSS) of Sleep Disorders. The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. The FSS is a short questionnaire (10 questions) that requires the subject to rate level of fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. Each statement is read and the corresponding number from 1 to 7 is circled. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. (Maximum bother = 70; No bother = 0) | Full analysis set (FAS) (consisted of all randomized participants who took at least 1 dose of study intervention) with available data at specified time point. | Posted | Mean | Standard Error | score on a scale | Baseline and week 12 |
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| 0 |
| 30 |
| 0 |
| 30 |
| 24 |
| 30 |
| EG001 | Comparator: Placebo/Saline (All Subjects) | Intervention: Placebo (as saline) given by subcutaneous injection on days 0, 28 and 56. This group is all women in the study that received placebo. | 0 | 30 | 0 | 30 | 20 | 30 |
| EG002 | Experimental: G-CSF (White, NH Subgroup) | Intervention: G-CSF (300 mcg/injection as filgrastim) given by subcutaneous injection on days 0, 28 and 56. This is a subgroup of the women in the study that received G-CSF and that self-identified as white, non-Hispanic. | 0 | 18 | 0 | 18 | 12 | 18 |
| EG003 | Comparator: Placebo/Saline (White, NH Subgroup) | Intervention: Placebo (as saline) given by subcutaneous injection on days 0, 28 and 56. This is a subgroup of the women in the study that received placebo and that self-identified as white, non-Hispanic. | 0 | 18 | 0 | 18 | 10 | 18 |
| Cold/Sinus | Infections and infestations | Systematic Assessment |
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| Nausea/GI Disorders | Gastrointestinal disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Musculo/Skeletal (not incl. bone pain) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Not provided
Not provided
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| 0.391 |
| Superiority |
Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates |
| Mixed Models Analysis |
| 0.085 |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
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| t-test, 1 sided | 0.395 | Superiority |
| Superiority |
| t-test, 1 sided | 0.152 | Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |