Progesterone for Perimenopausal Night Sweats

Hot Flushes Clinical Trial

Official title: Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms

Status Completed

Clinical Trial Summary

The purpose of this study is to test whether a oral micronized progesterone reduces the Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats in perimenopausal women. Oral micronized progesterone is molecularly identical to human progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial cancer in women taking estrogen in menopause. This research study will test whether progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether progesterone improves sleep disturbances and anxiety.

Clinical Trial Description

This is a randomized, double-blind 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. ;

Related Conditions & MeSH terms

• Hot Flashes
• Hot Flushes
• Night Sweats

• NCT number: NCT01464697
• Study type: Interventional
• Source: University of British Columbia
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Completion date: June 1, 2018