NCT01464697

Progesterone for Perimenopausal Night Sweats

Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 35 Years – 58 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hot Flushes
• Night Sweats

Interventions

Type	Name	Description
DRUG	Oral micronized progesterone	300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
DRUG	placebo	placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks

Timeline

• Start date: 2011-10-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2011-11-03
• Last updated: 2019-12-16
• Results posted: 2019-12-16

Locations

1 site across 1 country: Canada