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Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

Primary Purpose

Perimenopause, Menstrual Cramps

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Oral Micronized Progesterone
Placebo
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perimenopause focused on measuring Progesterone, Menstrual Flow

Eligibility Criteria

35 Years - 58 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Progesterone

Placebo

Arm Description

Oral micronized progesterone, 300 mg po daily, taken as three capsules daily before sleep for three months

Placebo, each taken as three capsules daily before sleep for three months

Outcomes

Primary Outcome Measures

Amount of menstrual fluid

Secondary Outcome Measures

Number of days of flow
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')

Full Information

First Posted
December 10, 2015
Last Updated
March 23, 2020
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02779582
Brief Title
Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow
Official Title
Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow: A Randomized, Double-masked, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perimenopause, Menstrual Cramps
Keywords
Progesterone, Menstrual Flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone
Arm Type
Experimental
Arm Description
Oral micronized progesterone, 300 mg po daily, taken as three capsules daily before sleep for three months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, each taken as three capsules daily before sleep for three months
Intervention Type
Drug
Intervention Name(s)
Oral Micronized Progesterone
Other Intervention Name(s)
progesterone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
pill with no effect
Primary Outcome Measure Information:
Title
Amount of menstrual fluid
Time Frame
daily for four months
Secondary Outcome Measure Information:
Title
Number of days of flow
Time Frame
daily for four months
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerilynn C Prior, MD, FRCPC
Organizational Affiliation
UBC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Vancouver Coastal Health Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

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