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Progesterone for Perimenopausal Night Sweats

NCT01464697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2019-12-16

Study results available
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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.

Conditions

  • Hot Flushes
  • Night Sweats

Interventions

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

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Jerilynn C Prior, MD, FRCPC · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
58 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464697 on ClinicalTrials.gov