Back to resultsProgesterone for Perimenopausal Night Sweats
Primary Purpose
Hot Flushes, Night Sweats
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Oral micronized progesterone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flushes focused on measuring hot flushes/hot flashes, night sweats, sleep problems, negative mood, anxiety, perimenopause, progesterone, vasomotor symptoms, depression, women's perceived change, perimenopause interference questionnaire
Eligibility Criteria
Inclusion Criteria:
- Between 35-58 years of age
- At least 4 vasomotor symptoms (VMS) per day, on average, for at least 2/4 weeks or at least 56 over a four-week period. In addition, women should report having VMS of moderate or severe rather than mild intensity. Women reporting fewer VMS than this, but who report night sweats that awaken them from sleep on two or more nights per week will also be included.
- Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.
- At least one menstrual period within 12 months of study enrollment
- Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.
- Ability to understand, speak, read and write English.
- Women who are at high risk for breast cancer (ie first degree relative with breast cancer, known/suspected history of breast cancer) will be required to have a normal mammogram and clinical breast examination within 12 months of study enrollment.
Exclusion Criteria:
- VMS without perimenopausal etiology.
- Women who have had a hysterectomy and/or ovariectomy.
- Peanut allergy (because peanut oil is used in the progesterone formulation.)
- Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen, progesterone, hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period. Two exceptions: women using progestin-releasing intrauterine device (IUD) will not be excluded as it is felt that level of hormone released will not have an effect on VMS and women taking very low-dose transdermal progesterone therapies who have VMS and meet inclusion criteria will be considered on a case-by-case basis. If enrolled, women with these exclusion exceptions will be required to continue and document use of these therapies throughout the entire trial.
- Planned pregnancy or fertility treatment during the study period.
- Women who are breastfeeding.
- Participants with a score greater or equal to 15 on the Personal Health Questionnaire (PHQ-9) will be assessed on a case-by-case basis. Women assessed as needing further investigation and/or treatment for depression will be excluded.
Sites / Locations
- Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Women's Health Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
oral micronized progesterone
Placebo Comparator
Arm Description
Oral micronized progesterone is Prometrium 300 mg at bedtime daily
Placebo
Outcomes
Primary Outcome Measures
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.
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.
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.
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).
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).
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).
Secondary Outcome Measures
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)
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)
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.
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.
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.
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)
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)
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)
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)
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)
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.
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.
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.
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.
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)
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)
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)
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.
Full Information
NCT ID
NCT01464697
First Posted
October 31, 2011
Last Updated
November 26, 2019
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01464697
Brief Title
Progesterone for Perimenopausal Night Sweats
Official Title
Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flushes, Night Sweats
Keywords
hot flushes/hot flashes, night sweats, sleep problems, negative mood, anxiety, perimenopause, progesterone, vasomotor symptoms, depression, women's perceived change, perimenopause interference questionnaire
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral micronized progesterone
Arm Type
Experimental
Arm Description
Oral micronized progesterone is Prometrium 300 mg at bedtime daily
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Oral micronized progesterone
Other Intervention Name(s)
Prometrium, Utrogestan
Intervention Description
300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
Primary Outcome Measure Information:
Title
Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks
Description
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
Title
Frequency of VMS
Description
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
Title
Severity of VMS
Description
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
Title
VMS Score by Early Perimenopause
Description
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
Title
VMS Score by Late Perimenopause
Description
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
Title
Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score
Description
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
Secondary Outcome Measure Information:
Title
Sleep Problems
Description
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
Title
Anxiety
Description
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
Title
Women's Perceived Changes in Daytime Hot Flushes for Whole Population
Description
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
Title
Women's Perceived Changes in Night Sweats for Whole Population
Description
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
Title
Women's Perceived Changes in Quality of Sleep for Whole Population
Description
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
Title
Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women
Description
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
Title
Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Early Perimenopause
Description
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
Title
Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Late Perimenopause
Description
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
Title
Perception of Interference of Perimenopausal Body Changes With Usual Activities in Women
Description
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
Title
Perception of Interference of Perimenopausal Mood Changes With Usual Activities in Women
Description
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
Title
Women's Perceived Changes in Daytime Hot Flushes in Early Perimenopause
Description
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
Title
Women's Perceived Changes in Night Sweats in Early Perimenopause
Description
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
Title
Women's Perceived Changes in Daytime Hot Flushes in Late Perimenopause
Description
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
Title
Women's Perceived Changes in Night Sweats in Late Perimenopause
Description
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
Title
Depression Related to Progesterone Therapy in Whole Population
Description
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
Title
Depression Related to Progesterone Therapy in Early Perimenopause
Description
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
Title
Depression Related to Progesterone Therapy in Late Perimenopause
Description
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
Title
Percentage of Women With Perceived Changes in Menstrual Flow
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 35-58 years of age
At least 4 vasomotor symptoms (VMS) per day, on average, for at least 2/4 weeks or at least 56 over a four-week period. In addition, women should report having VMS of moderate or severe rather than mild intensity. Women reporting fewer VMS than this, but who report night sweats that awaken them from sleep on two or more nights per week will also be included.
Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.
At least one menstrual period within 12 months of study enrollment
Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.
Ability to understand, speak, read and write English.
Women who are at high risk for breast cancer (ie first degree relative with breast cancer, known/suspected history of breast cancer) will be required to have a normal mammogram and clinical breast examination within 12 months of study enrollment.
Exclusion Criteria:
VMS without perimenopausal etiology.
Women who have had a hysterectomy and/or ovariectomy.
Peanut allergy (because peanut oil is used in the progesterone formulation.)
Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen, progesterone, hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period. Two exceptions: women using progestin-releasing intrauterine device (IUD) will not be excluded as it is felt that level of hormone released will not have an effect on VMS and women taking very low-dose transdermal progesterone therapies who have VMS and meet inclusion criteria will be considered on a case-by-case basis. If enrolled, women with these exclusion exceptions will be required to continue and document use of these therapies throughout the entire trial.
Planned pregnancy or fertility treatment during the study period.
Women who are breastfeeding.
Participants with a score greater or equal to 15 on the Personal Health Questionnaire (PHQ-9) will be assessed on a case-by-case basis. Women assessed as needing further investigation and/or treatment for depression will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerilynn C Prior, MD, FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Women's Health Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
22453200
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
http://www.cemcor.ca
Description
Centre for Menstrual Cycle and Ovulation Research
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Progesterone for Perimenopausal Night Sweats
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