Oral Micronized Progesterone Beneficial for Perimenopausal Hot Flushes/Flashes and Night Sweats
Presentation Number: OR25-7
Date of Presentation: March 19, 2018, 2018
Jerilynn C. Prior, MD1, Andrea Cameron, RN, BS, MSc1, Christine Laura Hitchcock, MA, PHD1, Michelle Fung, MD, MHSc2, Patricia Janssen, PhD1, Elana Brief, PhD1, Terry Lee, PhD1, Sandra Michelle Sirrs, MD,FRCP3, Shirin Kalyan, PhD1, Joel Singer, PhD1.
1University of British Columbia, Vancouver, BC, Canada, 2William Osler Health System, Brampton, ON, Canada, 3Vancouver General Hosp, Vancouver, BC, Canada.
Vasomotor symptoms (VMS) are experienced by 80% of perimenopausal women and severe for 9%. Yet no effective, safe, evidence-based VMS therapy exists for women who had flow within 1-year. Higher, erratic estradiol and lower progesterone levels1 make oral micronized progesterone (OMP) a sensible VMS option in perimenopause and likely safer than today’s estrogen-based HT or combined hormonal contraceptives. A similar RCT of OMP for menopausal (≥1-y without flow) VMS found a significant 4-point difference between OMP and placebo2. Methods: This Canada-wide, peer reviewed, federally funded, placebo-controlled RCT compared OMP 300 mg at bedtime with identical placebo over a 3-month experimental phase. The study aimed to detect a clinically important 3-point difference in daily diary-derived VMS Score (night and day, intensity and number) between therapies by the 3rd month. Participants were stratified by ‘early’ (no skipped period) or ‘late’ perimenopause. Secondary outcomes were self-reported change in VMS intensity and number, rated from much worse (+5) to much better (-5) at the last visit. Results: We screened 260 women (ages 35-58) for “bothersome VMS” (2/week night sweat awakings or 56 VMS/4-weeks). We randomized 189 eligible participants with mean age 50 and BMI 26.8; 57% were university graduates and 66% had skipped a cycle. Night sweats awakened 98% more than twice weekly. Groups were similar at baseline, including VMS Scores. VMS Scores were highly variable (mean, SD)=(12.2, 11.3). VMS Scores (3rd month) were OMP=5.5 (8.2) vs placebo=7.1 (10.4), P=0.191; the 95% CI of difference in Score change: -4.00, 0.84. At the 2nd month, OMP was significantly better than placebo: progesterone 5.3(7.0), placebo 8.0(11.2), P=0.04). Self-reported, perceived decreases in intensity were significantly greater on OMP for both day and night VMS (median: -3 vs -1 for each; P values=0.014 and <0.001) and for total night sweats and number (median: -3 vs -2 for each; P values=0.023 and 0.015). Those in ‘early’ perimenopause appreciated similar benefits. No serious adverse events occurred and 93% completed the RCT; adherence by pill counts was high (OMP 91.4%; placebo 84.4%). Interpretation: This first ever perimenopause VMS hormonal and RCT of oral micronized progesterone (300 mg/hs) for hot flush/flash and night sweat therapy demonstrated no serious adverse effects and may be effective for VMS in perimenopausal women. 1Prior Endocr Rev 1998; 2Hitchcock Menopause 2012.*Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.
J.C. Prior: None. A. Cameron: None. C.L. Hitchcock: None. M. Fung: None. P. Janssen: None. E. Brief: None. T. Lee: None. S.M. Sirrs: None. S. Kalyan: Research Investigator; Self; Qu Biologics. J. Singer: None.