drugset / Trial / NCT02779582

Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

NCT02779582

Phase 3 Completed 59 enrolled University of British Columbia
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to evaluate the within-woman effect of oral micronized progesterone (Progesterone 300 mg at bedtime) on semi-quantitative menstrual flow measured by the DivaCup® (menstrual cup with volume indicators at 7.5, 15 and 30 ml) or by counting the number of soaked normal-sized sanitary products such as normal-sized tampons or pads as well as length of flow and frequency and severity of menstrual cramps (on a 0-4 scale) in women with hot flushes and night sweats who are qualified to enroll in the primary perimenopausal hot flush trial stratified by whether they are in Early or Late Perimenopause.

Timeline

Start
2015-06
Primary completion
2018-06-01
Completion
2018-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Progesterone Other / unclassified 300 mg Oral