Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
This is a randomized, 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Vasomotor Symptoms (VMS)/ VMS Score
Participants will complete a daily diary (Daily Perimenopause Diary; www.cemcor.ubc.ca) 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.
Jerilynn C Prior, MD FRCPC
University of British Columbia
Canada: Health Canada