A Phase 3 interventional study of Oral micronized progesterone and placebo in Hot Flushes and Night Sweats, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to female participants aged 35 Years to 58 Years. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by University of British Columbia · Phase 3, Interventional, and Treatment
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.
293 studies on the registry are indexed under Hot Flashes; 52 are open to participants now.
This study's enrollment of 249 is above the median of 90 across 262 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Oral micronized progesterone is Prometrium 300 mg at bedtime daily
Drug: Oral micronized progesterone
Placebo
Drug: placebo
300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
Also known as: Prometrium, Utrogestan
placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 12 weeks
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).
Time frame: 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).
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 12 weeks
| Milestone | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Started | 93 | 96 |
| Completed | 90 | 86 |
| Not completed | 3 | 10 |
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.
| Units of Vasomotor Symptom Score | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks | 5.5 ± 8.2 | 7.1 ± 10.4 |
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.
| episodes per day | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Frequency of VMS | 2.4 ± 2.7 | 3.0 ± 3.7 |
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.
| Units on a Scale of 0-4 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Severity of VMS | 1.4 ± 1.0 | 1.5 ± 1.0 |
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).
| Units of Vasomotor Symptom Score | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| VMS Score by Early Perimenopause | 4.4 ± 7.4 | 3.9 ± 4.0 |
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).
| Units of Vasomotor Symptom Score | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| VMS Score by Late Perimenopause | 5.9 ± 8.5 | 8.8 ± 12.3 |
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).
| Units of Vasomotor Symptom Score | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score | 11.8 ± 9.0 | 15.1 ± 17.1 |
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)
| Units on a ordinal Scale | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Sleep Problems | 0.8 ± 0.8 | 1.0 ± 0.9 |
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)
| Units on a ordinal Scale | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Anxiety | 0.5 ± 0.6 | 0.6 ± 0.8 |
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.
| Change Scale -5 to +5, no change is 0 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Women's Perceived Changes in Daytime Hot Flushes for Whole Population | -2.3 ± 2.3 | -1.8 ± 2.3 |
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.
| Change Scale -5 to +5, no change is 0 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Women's Perceived Changes in Night Sweats for Whole Population | -2.5 ± 2.0 | -1.9 ± 2.0 |
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.
| Change Scale -5 to +5, no change is 0 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Women's Perceived Changes in Quality of Sleep for Whole Population | 2.0 (0.0 to 4.0) | 0.0 (0.0 to 3.0) |
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)
| Visual Analogue scale 0-100 mm | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women | 22.6 ± 18.3 | 28.2 ± 21.7 |
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)
| Visual Analogue scale 0-100 mm | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Early Perimenopause | 25.7 ± 20.2 | 33.0 ± 22.7 |
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)
| Visual Analogue scale 0-100 mm | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Late Perimenopause | 21.3 ± 17.5 | 25.6 ± 20.9 |
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)
| Visual Analogue scale 0-100 mm | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Perception of Interference of Perimenopausal Body Changes With Usual Activities in Women | 22.4 ± 20.1 | 27.8 ± 24.2 |
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)
| Visual Analogue scale 0-100 mm | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Perception of Interference of Perimenopausal Mood Changes With Usual Activities in Women | 22.7 ± 20.1 | 29.3 ± 23.5 |
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.
| Change Scale -5 to +5, no change is 0 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Women's Perceived Changes in Daytime Hot Flushes in Early Perimenopause | -1.7 ± 2.9 | -1.3 ± 1.8 |
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.
| Change Scale -5 to +5, no change is 0 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Women's Perceived Changes in Night Sweats in Early Perimenopause | -2.9 ± 1.9 | -1.9 ± 1.6 |
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.
| Change Scale -5 to +5, no change is 0 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Women's Perceived Changes in Daytime Hot Flushes in Late Perimenopause | -2.5 ± 2.1 | -2.0 ± 2.4 |
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.
| Change Scale -5 to +5, no change is 0 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Women's Perceived Changes in Night Sweats in Late Perimenopause | -2.4 ± 2.1 | -1.9 ± 2.2 |
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)
| PHQ9 Scale: 0-27 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Depression Related to Progesterone Therapy in Whole Population | 4.8 ± 4.4 | 5.4 ± 4.3 |
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)
| PHQ9 Scale: 0-27 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Depression Related to Progesterone Therapy in Early Perimenopause | 6.0 ± 4.6 | 5.4 ± 3.6 |
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)
| PHQ9 Scale: 0-27 | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Depression Related to Progesterone Therapy in Late Perimenopause | 4.4 ± 4.3 | 5.4 ± 4.6 |
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.
| Participants | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Percentage of Women With Perceived Changes in Menstrual Flow | 65 | 74 |
Collected over From randomization until the final questionnaire the day after the last experimental therapy, up to 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Micronized Progesterone | 0/93 (0%) | 0/93 (0%) | 22/93 (23.7%) |
| Placebo Comparator | 0/96 (0%) | 0/96 (0%) | 8/96 (8.3%) |
| Event | Oral Micronized Progesterone | Placebo Comparator |
|---|---|---|
| Nausea, GI tract problemsGastrointestinal disorders | 8/93 | 1/96 |
| Musculoskeletal, arthritis, connective tissue issuesMusculoskeletal and connective tissue disorders | 6/93 | 1/96 |
| Edema, atrial fibrillation, increased blood pressure, and headacheCardiac disorders | 5/93 | 3/96 |
| DizzinessGeneral disorders | 1/93 | 1/96 |
| Probable depressionPsychiatric disorders | 1/93 | 0/96 |
| Facial acneSkin and subcutaneous tissue disorders | 1/93 | 0/96 |
| Worsening VMSReproductive system and breast disorders | 0/93 | 1/96 |
| Post-traumatic stressPsychiatric disorders | 0/93 | 1/96 |
| Age, Categorical(Participants) | Oral Micronized Progesterone | Placebo Comparator | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 93 | 96 | 189 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Oral Micronized Progesterone | Placebo Comparator | Total |
|---|---|---|---|
| Mean | 49.4 ± 5.0 | 50.4 ± 4.2 | 49.9 ± 4.6 |
| Sex: Female, Male(Participants) | Oral Micronized Progesterone | Placebo Comparator | Total |
|---|---|---|---|
| Female | 93 | 96 | 189 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Oral Micronized Progesterone | Placebo Comparator | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 2 | 9 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 83 | 82 | 165 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 4 | 8 |
| Region of Enrollment(participants) | Oral Micronized Progesterone | Placebo Comparator | Total |
|---|---|---|---|
| Canada | 93 | 96 | 189 |
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Studies of the drug tested here: Progesterone
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