Clinical trial NCT02779582: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perimenopause
Menstrual Cramps
Keywords: Progesterone
Menstrual Flow
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 59
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Amount of menstrual fluid
timeFrame: daily for four months
Secondary outcomes:
measure: Number of days of flow
timeFrame: daily for four months
measure: 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')
timeFrame: daily for fourth months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Vancouver Coastal Health Research Institute
state: British Columbia
Study officials:
affiliation: UBC
name: Jerilynn C Prior, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: