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Oral micronized progesterone for vasomotor symptomsa placebo-controlled randomized trial in healthy postmenopausal women

Hitchcock, Christine L. PhD; Prior, Jerilynn C. BA, MD

Menopause:
doi: 10.1097/gme.0b013e318247f07a
Original Articles
Abstract

Objective: The aim of this study was to compare oral micronized progesterone (progesterone) with placebo as therapy for postmenopausal hot flushes and night sweats (vasomotor symptoms [VMS]).

Methods: Healthy volunteer community women 1 to 10 years since final menstruation were recruited for a randomized double-blind placebo-controlled trial of progesterone (300 mg daily at bedtime) between 2003 and 2009 and were screened for clinical, physical, or laboratory evidence of cardiovascular risks (nonsmoking, moderate body mass index [<35 kg/m2], normal lipids, electrocardiogram, nondiabetic). Women recorded daily frequency and severity (1-4) of VMS in the Daily Menopause Diary during run-in (4 wk) and intervention (12 wk). Average daily VMS score (day frequency × day severity + night frequency × night severity) during final 28 therapy days was the primary outcome, analyzed by therapy, with run-in score as covariate.

Results: Randomized participants were 133 healthy community women with VMS, ages 44 to 62 years, with a mean (SD) VMS score of 17.0 (10.4) at run-in (VMS frequency 6.8 [3.2] episodes/d). Women were randomized to progesterone (n = 75) or placebo (n = 58); analysis included all with VMS data at run-in and on therapy (n = 68 and 46, respectively). The VMS scores of women taking progesterone were better than placebo (mean adjusted difference, −4.3 (95% CI, −6.6 to −1.9), with mean reductions of 10.0 (95% CI, −12.0 to −8.1) and 4.4 (95% CI, −6.6 to −2.2) in the progesterone and placebo arms, respectively. Discontinuation with adverse events was 9% (progesterone, 8; placebo, 4), with no serious cases.

Conclusions: Oral micronized progesterone is effective for treatment of hot flushes and night sweats in healthy women early in postmenopause.

Author Information

From the Centre for Menstrual Cycle and Ovulation Research (CeMCOR), Division of Endocrinology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; and Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada.

Received October 27, 2011; revised and accepted December 22, 2011.

Funding/support: This study was funded by private individuals’ donations to the University of British Columbia’s Centre for Menstrual Cycle and Ovulation Research (CeMCOR). Active drug and placebo were provided initially by Schering (Canada) and subsequently by Besins Healthcare International.

Financial disclosure/conflicts of interest: None reported.

The authors had independent control of research design, study administration, analysis, and publication. Donors and providers of study drugs played no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.

ClinicalTrials.gov: NCT00152438.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.menopause.org).

Address correspondence to: Christine L. Hitchcock, PhD, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), Division of Endocrinology, Department of Medicine, University of British Columbia, and Vancouver Coastal Health Research Institute, 2775 Laurel St, 4th Floor, Vancouver, BC, Canada V5Z 1M9. E-mail: chris.hitchcock@ubc.ca

©2012The North American Menopause Society