Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jerilynn Prior, University of British Columbia
First received: October 31, 2011
Last updated: May 8, 2017
Last verified: May 2017
The purpose of this study is to test whether a oral micronized progesterone reduces the Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats in perimenopausal women. Oral micronized progesterone is molecularly identical to human progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial cancer in women taking estrogen in menopause. This research study will test whether progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether progesterone improves sleep disturbances and anxiety.
Drug: Oral micronized progesterone
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
||Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
Primary Outcome Measures:
- Vasomotor Symptoms (VMS)/ VMS Score [ Time Frame: 12 weeks ]
Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency and severity (quantified by numerical scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows:
Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
Secondary Outcome Measures:
- Frequency of VMS [ Time Frame: 12 weeks ]
Frequency (count) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Outcome is the average daily VMS Frequency (day + night) during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
- Severity of VMS [ Time Frame: 12 weeks ]
Severity (0-4) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Daily summary score is the maximum of daytime and nighttime severity. Outcome is the average daily severity during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
- Sleep problems and anxiety [ Time Frame: 12 weeks ]
Daily average rating of sleep problems (0-4) and anxiety (0-4) from prospective daily calendar records.
Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2017 (Final data collection date for primary outcome measure)
Experimental: oral micronized progesterone
Oral micronized progesterone is Prometrium 300 mg at bedtime daily
Drug: Oral micronized progesterone
300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
Placebo Comparator: Placebo Comparator
placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
This is a randomized, double-blind placebo-controlled trial of oral micronized progesterone (300 mg daily at bedtime) for perimenopausal women living anywhere in Canada. Using the self-reported maximum menstrual cycle length in the previous year, women will be stratified as in Early Perimenopause (<60 days) or Late Perimenopause (>=60 days). The design includes a 28-day baseline run-in followed by 12 weeks of randomized therapy.
|Ages Eligible for Study:
||35 Years to 58 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Between 35-58 years of age
- At least 4 vasomotor symptoms (VMS) per day, on average, for at least 2/4 weeks or at least 56 over a four-week period. In addition, women should report having VMS of moderate or severe rather than mild intensity. Women reporting fewer VMS than this, but who report night sweats that awaken them from sleep on two or more nights per week will also be included.
- Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.
- At least one menstrual period within 12 months of study enrollment
- Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.
- Ability to understand, speak, read and write English.
- Women who are at high risk for breast cancer (ie first degree relative with breast cancer, known/suspected history of breast cancer) will be required to have a normal mammogram and clinical breast examination within 12 months of study enrollment.
- VMS without perimenopausal etiology.
- Women who have had a hysterectomy and/or ovariectomy.
- Peanut allergy (because peanut oil is used in the progesterone formulation.)
- Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen, progesterone, hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period. Two exceptions: women using progestin-releasing intrauterine device (IUD) will not be excluded as it is felt that level of hormone released will not have an effect on VMS and women taking very low-dose transdermal progesterone therapies who have VMS and meet inclusion criteria will be considered on a case-by-case basis. If enrolled, they will be required to continue and document use of this very low-dose hormone therapy throughout the entire trial.
- Planned pregnancy or fertility treatment during the study period.
- Women who are breastfeeding.
- Participants with a score greater or equal to 15 on the Personal Health Questionnaire (PHQ-9) will be assessed on a case-by-case basis. Women assessed as needing further investigation and/or treatment for depression will be excluded.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01464697
|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 |
University of British Columbia
||Jerilynn C Prior, MD FRCPC
||University of British Columbia
Prior JC, Hitchcock, CL. Progesterone for Vasomotor Symptoms: A 12-week Randomized, Masked Placebo-controlled Trial in Healthy, Normal-Weight Women 1-10 Years Since Final Menstrual Flow (Abstract). Endocrine Reviews 31(3): S51, 2010.
||Jerilynn Prior, Principal Investigator, University of British Columbia
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 31, 2011
||May 8, 2017
|Individual Participant Data (IPD) Sharing Statement:
|Plan to Share IPD:
Keywords provided by Jerilynn Prior, University of British Columbia:
hot flushes/hot flashes
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 25, 2017
Signs and Symptoms
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs