Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

Perimenopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779582
• Other study ID #: H10-02975_1
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: March 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 58 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Menstrual Cramps
• Perimenopause

Intervention

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.
• Placebo
pill with no effect

Locations

Country	Name	City	State
Canada	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

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of menstrual fluid		daily for four months
Secondary	Number of days of flow		daily for four months
Secondary	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')		daily for fourth months