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Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

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ClinicalTrials.gov Identifier: NCT02779582
Recruitment Status : Unknown
Verified May 2017 by Jerilynn Prior, University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2016
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Jerilynn Prior, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Perimenopause Menstrual Cramps Drug: Oral Micronized Progesterone Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow: A Randomized, Double-masked, Placebo-controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Progesterone
Oral micronized progesterone, 300 mg po daily, taken as three capsules daily before sleep for three months
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.
Other Name: progesterone

Placebo Comparator: Placebo
Placebo, each taken as three capsules daily before sleep for three months
Drug: Placebo
pill with no effect




Primary Outcome Measures :
  1. Amount of menstrual fluid [ Time Frame: daily for four months ]

Secondary Outcome Measures :
  1. Number of days of flow [ Time Frame: daily for four months ]
  2. 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') [ Time Frame: daily for fourth months ]


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Ages Eligible for Study:   35 Years to 58 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779582


Locations
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Canada, British Columbia
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, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Jerilynn C Prior, MD, FRCPC UBC

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Responsible Party: Jerilynn Prior, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02779582     History of Changes
Other Study ID Numbers: H10-02975_1
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jerilynn Prior, University of British Columbia:
Progesterone
Menstrual Flow

Additional relevant MeSH terms:
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Progesterone
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs