Progesterone for hot flush and night sweat treatment – effectiveness for severe vasomotor symptoms and lack of withdrawal rebound

Abstract

A controlled trial recently showed that oral micronized progesterone (Progesterone, 300 mg at h.s. daily) was effective for vasomotor symptoms (VMS) in 133 healthy early postmenopausal women. Here, we present subgroup data in women with severe VMS (50 VMS of moderate–severe intensity/wk) and also 1-mo withdrawal study outcomes. Women with severe VMS (n = 46) resembled the full cohort but experienced 10 VMS/d of 3 of 4 intensity. On therapy, the progesterone VMS number (#) decreased significantly more than placebo # to 5.5/day (d) versus 8/d (ANCOVA −2.0 95% CI: −3.5 to −0.4). Just after trial mid-point, a withdrawal substudy (D/C) was added – 56 women were invited and 34 (61%) took part (progesterone 17; placebo 17). Those in the D/C cohort resembled the whole cohort. On stopping, VMS gradually increased – at D/C week 4, on progesterone, VMS daily # reached 78% and significantly less than baseline (−3.0 to −0.8) but placebo VMS # did not differ from run-in. In summary, progesterone is effective for severe VMS and does not cause a rebound increase in VMS when stopped. That progesterone may be used alone for severe VMS and unlike estrogen does not appear to cause a withdrawal rebound increases VMS treatment options.

Keywords::

• Hot flushes
• progesterone
• night sweats
• withdrawal syndrome
• postmenopause
• insomnia
• cardiovascular disease
• social stress

Acknowledgements

We appreciate the many individuals whose donations to the Centre for Menstrual Cycle and Ovulation Research (CeMCOR) made these trial data possible. We also thank all the women who took part and kept careful records. We thank Besins Healthcare for generous donation of drug and placebo and their former clinical trials manager, Dr. Aude Beliard, for facilitating this important donation.

Declaration of Interest: Neither author has any financial conflicts of interest. One author experienced severe peri- and postmenopausal VMS and was effectively treated with oral micronized progesterone. Both are affiliated with the Centre for Menstrual Cycle and Ovulation Research, a not-for-profit research and knowledge translation unit associated with both the University of British Columbia and with the Vancouver Coastal Health Research Institute.