Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia
• Treatments: Progesterone

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