Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Perimenopause, Menstrual Cramps

Intervention / Treatment
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* Drug: Oral Micronized Progesterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 58 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progesterone<br>Oral micronized progesterone, 300 mg po daily, taken as three capsules daily before sleep for three months | Drug: Oral Micronized Progesterone<br>* 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.<br>* Other names: progesterone;|
| Placebo Comparator: Placebo<br>Placebo, each taken as three capsules daily before sleep for three months | Drug: Placebo<br>* pill with no effect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of menstrual fluid |  | daily for four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days of flow |  | daily for four months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progesterone, Menstrual Flow