Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
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ClinicalTrials.gov Identifier: NCT01464697 |
Recruitment Status :
Active, not recruiting
First Posted : November 3, 2011
Last Update Posted : May 9, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hot Flushes Night Sweats | Drug: Oral micronized progesterone Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 249 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms |
Study Start Date : | October 2011 |
Estimated Primary Completion Date : | June 2017 |
Estimated Study Completion Date : | June 2017 |

Arm | Intervention/treatment |
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Experimental: oral micronized progesterone
Oral micronized progesterone is Prometrium 300 mg at bedtime daily
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Drug: Oral micronized progesterone
300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
Other Names:
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Placebo Comparator: Placebo Comparator
Placebo
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Drug: placebo
placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks |
- 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.
- 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.

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Ages Eligible for Study: | 35 Years to 58 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

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): NCT01464697
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 |
Principal Investigator: | Jerilynn C Prior, MD FRCPC | University of British Columbia |
Additional Information:
Publications:
Responsible Party: | Jerilynn Prior, Principal Investigator, University of British Columbia |
ClinicalTrials.gov Identifier: | NCT01464697 History of Changes |
Other Study ID Numbers: |
H10-02975 |
First Posted: | November 3, 2011 Key Record Dates |
Last Update Posted: | May 9, 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:
hot flushes/hot flashes night sweats sleep problems negative mood anxiety |
perimenopause progesterone vasomotor symptoms premenopause |
Additional relevant MeSH terms:
Hot Flashes Signs and Symptoms Progesterone Progestins |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |