Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

NCT02779582 | Completed Phase 3

• 1 other identifier: H10-02975_1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Perimenopause; Menstrual Cramps

Keywords

Progesterone; Menstrual Flow

Outcome Measures

Primary Outcomes (1)

• Amount of menstrual fluid

  daily for four months

Secondary Outcomes (2)

• 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

Study Arms (2)

Progesterone

EXPERIMENTAL

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

Drug: Oral Micronized Progesterone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Oral Micronized Progesterone 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.

Also known as: progesterone

Progesterone

Placebo DRUG

pill with no effect

Placebo

Eligibility Criteria

• Age: 35 Years - 58 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

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, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Jerilynn C Prior, MD, FRCPC

  UBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: May 20, 2016
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)