Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

University of British Columbia

Status and phase

Completed

Phase 3

Conditions

Menstrual Cramps

Perimenopause

Treatments

Drug: Oral Micronized Progesterone

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02779582

H10-02975_1

Details and patient eligibility

About

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 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.

Enrollment

59 patients

Sex

Female

Ages

35 to 58 years old

Volunteers

Accepts 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