Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

NCT ID: NCT02779582

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-06-01

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.

Conditions

Perimenopause; Menstrual Cramps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Progesterone

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

Group Type: EXPERIMENTAL

Oral Micronized Progesterone

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

pill with no effect

Interventions

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.

Intervention Type: DRUG

Placebo

pill with no effect

Intervention Type: DRUG

Other Intervention Names

progesterone

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jerilynn Prior

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerilynn C Prior, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

UBC

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

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H10-02975_1

Identifier Type: -

Identifier Source: org_study_id