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The purpose of this study is to test whether a oral micronized progesterone reduces the Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats in perimenopausal women. Oral micronized progesterone is molecularly identical to human progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial cancer in women taking estrogen in menopause. This research study will test whether progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether progesterone improves sleep disturbances and anxiety.
This is a randomized, double-blind placebo-controlled trial of oral micronized progesterone (300 mg daily at bedtime) for perimenopausal women living anywhere in Canada. Using the self-reported maximum menstrual cycle length in the previous year, women will be stratified as in Early Perimenopause (<60 days) or Late Perimenopause (>=60 days). The design includes a 28-day baseline run-in followed by 12 weeks of randomized therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral micronized progesterone | Experimental | Oral micronized progesterone is Prometrium 300 mg at bedtime daily |
|
| Placebo Comparator | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral micronized progesterone | Drug | 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks | Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. | 12 weeks |
| Frequency of VMS | Frequency (count) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Outcome is the average daily VMS Frequency (day + night) during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. | 12 weeks |
| Severity of VMS | Severity (0-4, 0=no intensity, 4=extreme intensity) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Daily summary score is the maximum of daytime and nighttime severity. Outcome is the average daily severity during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. | 12 weeks |
| VMS Score by Early Perimenopause | subgroup analysis of VMS Score by Early Perimenopause (no skipped period or <60 day cycle length). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). | 12 weeks |
| VMS Score by Late Perimenopause |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Problems | Daily average rating of sleep problems (0-4) from prospective daily calendar records. Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Scale name: Sleep Problems (4=Worst, 0=None) | 12 weeks |
| Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerilynn C Prior, MD, FRCPC | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Women's Health Research Institute | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Prior JC, Hitchcock, CL. Progesterone for Vasomotor Symptoms: A 12-week Randomized, Masked Placebo-controlled Trial in Healthy, Normal-Weight Women 1-10 Years Since Final Menstrual Flow (Abstract). Endocrine Reviews 31(3): S51, 2010. | ||
| 22453200 | Background | Hitchcock CL, Prior JC. Oral micronized progesterone for vasomotor symptoms--a placebo-controlled randomized trial in healthy postmenopausal women. Menopause. 2012 Aug;19(8):886-93. doi: 10.1097/gme.0b013e318247f07a. | |
| Background | Prior JC, Cameron A, Hitchcock CL, et al. Oral Micronized Progesterone Beneficial for Perimenopausal Hot Flushes/Flashes and Night Sweats. Endocrine Reviews 2018;39(2) Abstract-oral presentation at Endocrine Society Conference, Chicago, 2018. |
| Label | URL |
|---|---|
| Centre for Menstrual Cycle and Ovulation Research | View source |
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Enrollment required meeting eligibility criteria by screening questionnaire but also required eligible hot flushes and night sweats on a 28-day Calendar. The difference between the listed enrolled and those who were randomized represents this fact.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Micronized Progesterone | Oral micronized progesterone is Prometrium 300 mg at bedtime daily Oral micronized progesterone: 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks |
| FG001 | Placebo Comparator | Placebo placebo: placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Micronized Progesterone | Oral micronized progesterone is Prometrium 300 mg at bedtime daily Oral micronized progesterone: 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks |
| BG001 | Placebo Comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks | Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. | Intent to Treat Population | Posted | Mean | Standard Deviation | Units of Vasomotor Symptom Score | 12 weeks |
|
From randomization until the final questionnaire the day after the last experimental therapy, up to 12 weeks.
We followed Best Clinical Practice Guidelines. All reported events were included. They were blindly classified by intensity and by potential relationship with the experimental therapy.
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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 | Oral Micronized Progesterone | Oral micronized progesterone is Prometrium 300 mg at bedtime daily Oral micronized progesterone: 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal, arthritis, connective tissue issues | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Given no previous RCT of VMS only in perimenopause, despite a blinded study assessment, we were still under powered. Women's Perceived Changes assessments, were not congruent with the VMS Score.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerilynn C. Prior, Professor | University of British Columbia | 6048755927 | jerilynn.prior@ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2018 | Oct 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| D020447 | Parasomnias |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| C000624167 | Utrogestan |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| placebo | Drug | placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks |
|
subgroup analysis of VMS Score by Late Perimenopause (those with skipped or ≥60 day cycle lengths). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). |
| 12 weeks |
| Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score | VMS Score for those with more frequent (≥7 per day and moderate to severe episodes of intensity 2-4) at baseline. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). | 12 weeks |
Daily average rating of anxiety (0-4) from prospective daily calendar records. Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Scale name: Anxiety (4=Worst, 0=None) |
| 12 weeks |
| Women's Perceived Changes in Daytime Hot Flushes for Whole Population | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire. Scale Name: Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks). No calculation is needed. | 12 weeks |
| Women's Perceived Changes in Night Sweats for Whole Population | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire. Scale Name: Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks). No calculation is needed. | 12 weeks |
| Women's Perceived Changes in Quality of Sleep for Whole Population | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in the quality of sleep over the three months of the trial as assessed by the Final Questionnaire based on their random assignment to the progesterone or placebo arms of this RCT (Randomized Controlled Trial) and by Early/Late perimenopause. Scale Name: Quality of Sleep Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks). No calculation is needed. | 12 weeks |
| Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women | Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR PIQ - Centre for Menstrual Cycle and Ovulation Research Perimenopause Interference Questionnaire) at 12 weeks in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | 12 weeks |
| Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Early Perimenopause | Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) at 12 weeks in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | 12 weeks |
| Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Late Perimenopause | Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) at 12 weeks in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | 12 weeks |
| Perception of Interference of Perimenopausal Body Changes With Usual Activities in Women | Final perceptions of interference of perimenopausal body changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | 12 weeks |
| Perception of Interference of Perimenopausal Mood Changes With Usual Activities in Women | Final perceptions of interference of perimenopausal mood changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | 12 weeks |
| Women's Perceived Changes in Daytime Hot Flushes in Early Perimenopause | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire and by subgroup for Early Perimenopause. Scale Name: Perceived Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. | 12 weeks |
| Women's Perceived Changes in Night Sweats in Early Perimenopause | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire and by subgroup for Early Perimenopause. Scale Name: Perceived Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. | 12 weeks |
| Women's Perceived Changes in Daytime Hot Flushes in Late Perimenopause | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire and by subgroup for Late Perimenopause. Scale Name: Perceived Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. | 12 weeks |
| Women's Perceived Changes in Night Sweats in Late Perimenopause | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire and by subgroup for Late Perimenopause. Scale Name: Perceived Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. | 12 weeks |
| Depression Related to Progesterone Therapy in Whole Population | Final PHQ9 (Personal Health Questionnaire 9) Score for Depression related to progesterone therapy in perimenopause will be assessed based on the Personal Health Questionnaire-9 (PHQ-9) score changes within-woman from baseline to the end-of-trial on progesterone compared with placebo. Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression) | 12 weeks |
| Depression Related to Progesterone Therapy in Early Perimenopause | Final PHQ9 Score for Depression related to progesterone therapy in Early Perimenopause will be assessed based on the Personal Health Questionnaire-9 (PHQ-9) score changes within-woman from baseline to the end-of-trial on progesterone compared with placebo. Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression) | 12 weeks |
| Depression Related to Progesterone Therapy in Late Perimenopause | Final PHQ9 Score for Depression related to progesterone therapy in Late Perimenopause will be assessed based on the Personal Health Questionnaire-9 (PHQ-9) score changes within-woman from baseline to the end-of-trial on progesterone compared with placebo. Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression) | 12 weeks |
| Percentage of Women With Perceived Changes in Menstrual Flow | Menstrual flow related to progesterone therapy in perimenopause was assessed based on Women's Perceived Changes Questionnaire of changes in the experience of menstrual flow/vaginal bleeding from the Final Questionnaire. | 12 weeks |
Placebo
placebo: placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo Comparator | Placebo placebo: placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks |
|
|
| Primary | Frequency of VMS | Frequency (count) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Outcome is the average daily VMS Frequency (day + night) during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. | Posted | Mean | Standard Deviation | episodes per day | 12 weeks |
|
|
|
| Primary | Severity of VMS | Severity (0-4, 0=no intensity, 4=extreme intensity) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Daily summary score is the maximum of daytime and nighttime severity. Outcome is the average daily severity during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. | Posted | Mean | Standard Deviation | Units on a Scale of 0-4 | 12 weeks |
|
|
|
| Primary | VMS Score by Early Perimenopause | subgroup analysis of VMS Score by Early Perimenopause (no skipped period or <60 day cycle length). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). | Posted | Mean | Standard Deviation | Units of Vasomotor Symptom Score | 12 weeks |
|
|
|
| Primary | VMS Score by Late Perimenopause | subgroup analysis of VMS Score by Late Perimenopause (those with skipped or ≥60 day cycle lengths). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). | Posted | Mean | Standard Deviation | Units of Vasomotor Symptom Score | 12 weeks |
|
|
|
| Primary | Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score | VMS Score for those with more frequent (≥7 per day and moderate to severe episodes of intensity 2-4) at baseline. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). | Posted | Mean | Standard Deviation | Units of Vasomotor Symptom Score | 12 weeks |
|
|
|
| Secondary | Sleep Problems | Daily average rating of sleep problems (0-4) from prospective daily calendar records. Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Scale name: Sleep Problems (4=Worst, 0=None) | Posted | Mean | Standard Deviation | Units on a ordinal Scale | 12 weeks |
|
|
|
| Secondary | Anxiety | Daily average rating of anxiety (0-4) from prospective daily calendar records. Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Scale name: Anxiety (4=Worst, 0=None) | Posted | Mean | Standard Deviation | Units on a ordinal Scale | 12 weeks |
|
|
|
| Secondary | Women's Perceived Changes in Daytime Hot Flushes for Whole Population | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire. Scale Name: Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks). No calculation is needed. | Posted | Mean | Standard Deviation | Change Scale -5 to +5, no change is 0 | 12 weeks |
|
|
|
| Secondary | Women's Perceived Changes in Night Sweats for Whole Population | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire. Scale Name: Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks). No calculation is needed. | Posted | Mean | Standard Deviation | Change Scale -5 to +5, no change is 0 | 12 weeks |
|
|
|
| Secondary | Women's Perceived Changes in Quality of Sleep for Whole Population | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in the quality of sleep over the three months of the trial as assessed by the Final Questionnaire based on their random assignment to the progesterone or placebo arms of this RCT (Randomized Controlled Trial) and by Early/Late perimenopause. Scale Name: Quality of Sleep Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks). No calculation is needed. | Posted | Mean | Full Range | Change Scale -5 to +5, no change is 0 | 12 weeks |
|
|
|
| Secondary | Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women | Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR PIQ - Centre for Menstrual Cycle and Ovulation Research Perimenopause Interference Questionnaire) at 12 weeks in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | Posted | Mean | Standard Deviation | Visual Analogue scale 0-100 mm | 12 weeks |
|
|
|
| Secondary | Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Early Perimenopause | Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) at 12 weeks in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | Posted | Mean | Standard Deviation | Visual Analogue scale 0-100 mm | 12 weeks |
|
|
|
| Secondary | Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Late Perimenopause | Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) at 12 weeks in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | Posted | Mean | Standard Deviation | Visual Analogue scale 0-100 mm | 12 weeks |
|
|
|
| Secondary | Perception of Interference of Perimenopausal Body Changes With Usual Activities in Women | Final perceptions of interference of perimenopausal body changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | Posted | Mean | Standard Deviation | Visual Analogue scale 0-100 mm | 12 weeks |
|
|
|
| Secondary | Perception of Interference of Perimenopausal Mood Changes With Usual Activities in Women | Final perceptions of interference of perimenopausal mood changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) in women randomized to the progesterone versus to placebo. Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference) | Posted | Mean | Standard Deviation | Visual Analogue scale 0-100 mm | 12 weeks |
|
|
|
| Secondary | Women's Perceived Changes in Daytime Hot Flushes in Early Perimenopause | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire and by subgroup for Early Perimenopause. Scale Name: Perceived Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. | Posted | Mean | Standard Deviation | Change Scale -5 to +5, no change is 0 | 12 weeks |
|
|
|
| Secondary | Women's Perceived Changes in Night Sweats in Early Perimenopause | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire and by subgroup for Early Perimenopause. Scale Name: Perceived Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. | Posted | Mean | Standard Deviation | Change Scale -5 to +5, no change is 0 | 12 weeks |
|
|
|
| Secondary | Women's Perceived Changes in Daytime Hot Flushes in Late Perimenopause | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire and by subgroup for Late Perimenopause. Scale Name: Perceived Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. | Posted | Mean | Standard Deviation | Change Scale -5 to +5, no change is 0 | 12 weeks |
|
|
|
| Secondary | Women's Perceived Changes in Night Sweats in Late Perimenopause | Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire and by subgroup for Late Perimenopause. Scale Name: Perceived Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. | Posted | Mean | Standard Deviation | Change Scale -5 to +5, no change is 0 | 12 weeks |
|
|
|
| Secondary | Depression Related to Progesterone Therapy in Whole Population | Final PHQ9 (Personal Health Questionnaire 9) Score for Depression related to progesterone therapy in perimenopause will be assessed based on the Personal Health Questionnaire-9 (PHQ-9) score changes within-woman from baseline to the end-of-trial on progesterone compared with placebo. Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression) | Posted | Mean | Standard Deviation | PHQ9 Scale: 0-27 | 12 weeks |
|
|
|
| Secondary | Depression Related to Progesterone Therapy in Early Perimenopause | Final PHQ9 Score for Depression related to progesterone therapy in Early Perimenopause will be assessed based on the Personal Health Questionnaire-9 (PHQ-9) score changes within-woman from baseline to the end-of-trial on progesterone compared with placebo. Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression) | Posted | Mean | Standard Deviation | PHQ9 Scale: 0-27 | 12 weeks |
|
|
|
| Secondary | Depression Related to Progesterone Therapy in Late Perimenopause | Final PHQ9 Score for Depression related to progesterone therapy in Late Perimenopause will be assessed based on the Personal Health Questionnaire-9 (PHQ-9) score changes within-woman from baseline to the end-of-trial on progesterone compared with placebo. Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression) | Posted | Mean | Standard Deviation | PHQ9 Scale: 0-27 | 12 weeks |
|
|
|
| Secondary | Percentage of Women With Perceived Changes in Menstrual Flow | Menstrual flow related to progesterone therapy in perimenopause was assessed based on Women's Perceived Changes Questionnaire of changes in the experience of menstrual flow/vaginal bleeding from the Final Questionnaire. | The discrepancy in the Number of Participants analyzed is due to missing data on the Final Questionnaire. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| 22 |
| 93 |
| EG001 | Placebo Comparator | Placebo placebo: placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks | 0 | 96 | 0 | 96 | 8 | 96 |
| Nausea, GI tract problems | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Edema, atrial fibrillation, increased blood pressure, and headache | Cardiac disorders | Systematic Assessment |
|
| Worsening VMS | Reproductive system and breast disorders | Systematic Assessment |
|
| Post-traumatic stress | Psychiatric disorders | Systematic Assessment |
|
| Probable depression | Psychiatric disorders | Systematic Assessment |
|
| Facial acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |