CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 249 enrolled
Drug / intervention
Oral micronized progesterone +1 moredrug
Likely dose
Oral micronized progesterone 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01464697
NCT01464697Phase 3Completed
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Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms

University of British Columbia·interventional·Posted Nov 3, 2011·Updated Dec 16, 2019

In Brief

A Phase 3 clinical trial evaluating Oral micronized progesterone and placebo for Hot Flushes and Night Sweats. Completed, enrolled 249 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHot Flushes, Night Sweats
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2011
Enrollment StartOct 1, 2011
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 14.7 years ago

Interventions

Oral micronized progesteronedrug

300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks

placebodrug

placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks