Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow: A Randomized, Double-masked, Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Perimenopause; Menstrual Cramps
• Intervention / Treatment: Drug: Oral Micronized Progesterone; Drug: Placebo

Detailed Description

The study will be a double-masked, placebo-controlled 28-day (4 week) baseline, 84-day (12 week) experimental trial, with a maximum number of 125 potential enrollees, with stratified random therapy assignment by Early or Late Perimenopause. Participants who meet the inclusion criteria for the original Progesterone for Perimenopausal Vasomotor Symptoms Study will be invited to join this additional sub-study. As part of the primary trial they will be randomly assigned into either the Progesterone or placebo group on a 1:1 basis. Primary and secondary data will be collected continuously throughout the study by completion of the Daily Perimenopause Diary-flow starting at baseline and continuously throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Vancouver Coastal Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• >35 to <58 years of age
• Willingness to participate in this sub-study
• Perimenopausal status either based on irregularity of menstrual periods, or by onset of hot flushes/night sweats in women with regular periods
• Ability and willingness to complete the -flow recording instrument
• Ability to understand, speak, read and write English.

Exclusion Criteria:

• Less than 35 or greater than 58 years of age
• More than 1-yr without menstrual flow at study enrollment, including those with a hysterectomy ± ovariectomy
• Peanut allergy (because peanut oil is used in the progesterone formulation)
• Current or recent (within 6-mo of study enrollment) use of hormonal therapies (estrogen, progesterone, progestin-releasing intrauterine device (IUD), hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period
• Planned pregnancy or fertility treatment during the study period
• Inability to understand, speak, read and write English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progesterone; Oral micronized progesterone, 300 mg po daily, taken as three capsules daily before sleep for three months	Drug: Oral Micronized Progesterone; The dose of 300 mg of Progesterone is a physiological one that maintains the serum progesterone at or above the luteal (normal post-ovulatory) threshold for 24 hours. This duration of action is important because Progesterone is not safely taken during waking hours because of its soporific effects.; Other Names: progesterone
Placebo Comparator: Placebo; Placebo, each taken as three capsules daily before sleep for three months	Drug: Placebo; pill with no effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of menstrual fluid	daily for four months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of days of flow	daily for four months
Severity of menstrual cramps measured by a self-reported scale between zero and four (i.e. zero means 'no cramps' and four means 'very intense cramps')	daily for fourth months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Jerilynn C Prior, MD, FRCPC, UBC

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Progesterone; Menstrual Flow
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: H10-02975_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No