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The randomized double-blind, placebo-controlled study by Hitchcock and Prior [1] demonstrates that oral micronized progesterone is more effective than placebo for the treatment of vasomotor symptoms (VMS) in early postmenopausal women. The study included 133 healthy community women with VMS, aged 44–62 years, 1–10 years since final menstruation. Women recorded daily frequency and severity (1–4) of VMS in the Daily Menopause Diary during run-in (4 weeks) and intervention (12 weeks). The average daily VMS score (day frequency × day severity + night frequency × night severity) during the final 28 therapy days was the primary outcome. A VMS score of 17.0 (SD 10.4) was recorded at run-in (VMS frequency 6.8 (SD 3.2) episodes/day). Women were then randomized to progesterone ([i]n[/i] = 75) or placebo ([i]n[/i] = 58). The VMS scores of women taking progesterone were better than those taking 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, [i]n[/i] = 8; placebo, [i]n[/i] = 4), with no serious cases. These data clearly demonstrated that VMS scores of women taking progesterone were significantly better than those taking placebo, and similar to those obtained in any HRT trials.


  • Marco Gambacciani
    Department of Reproductive Medicine and Child Development, Division of Obstetrics & Gynecology ‘P. Fioretti, Pisa University Hospital, Pisa, Italy


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