Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
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|ClinicalTrials.gov Identifier: NCT01464697|
Recruitment Status : Active, not recruiting
First Posted : November 3, 2011
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hot Flushes Night Sweats||Drug: Oral micronized progesterone Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: oral micronized progesterone
Oral micronized progesterone is Prometrium 300 mg at bedtime daily
Drug: Oral micronized progesterone
300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
Placebo Comparator: Placebo Comparator
placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
- Vasomotor Symptoms (VMS)/ VMS Score [ Time Frame: 12 weeks ]
Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency and severity (quantified by numerical 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 [ Time Frame: 12 weeks ]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 [ Time Frame: 12 weeks ]Severity (0-4) 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.
- Sleep problems and anxiety [ Time Frame: 12 weeks ]
Daily average rating of sleep problems (0-4) and 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464697
|Canada, British Columbia|
|Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Vancouver Coastal Health Research Institute|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Jerilynn C Prior, MD FRCPC||University of British Columbia|