Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

Overview

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.

Full Title of Study: “Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow: A Randomized, Double-masked, Placebo-controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 1, 2018

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.

Interventions

  • 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.
  • Drug: Placebo
    • pill with no effect

Arms, Groups and Cohorts

  • Experimental: Progesterone
    • Oral micronized progesterone, 300 mg po daily, taken as three capsules daily before sleep for three months
  • Placebo Comparator: Placebo
    • Placebo, each taken as three capsules daily before sleep for three months

Clinical Trial Outcome Measures

Primary Measures

  • Amount of menstrual fluid
    • Time Frame: daily for four months

Secondary Measures

  • Number of days of flow
    • Time Frame: 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’)
    • Time Frame: daily for fourth months

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 35 Years

Maximum Age: 58 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jerilynn Prior, Principal Investigator – University of British Columbia
  • Overall Official(s)
    • Jerilynn C Prior, MD, FRCPC, Principal Investigator, UBC

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