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Completed

NCT Number: NCT02779582

Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

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.

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Key information

Conditions

Perimenopause Dysmenorrhea Menstrual Cramps Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

35 year–58 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Micronized Progesterone

Drug

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

Drug

pill with no effect

Primary outcomes

  1. Amount of menstrual fluid

    Time frame: daily for four months

Secondary outcomes

  1. Number of days of flow

    Time frame: daily for four months

  2. 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 20, 2016
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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