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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
Sponsor:
Information provided by (Responsible Party):
Jerilynn Prior, University of British Columbia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hot Flushes Night Sweats Drug: Oral micronized progesterone Drug: placebo Phase 3

Detailed Description:
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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • Prometrium
  • Utrogestan
Placebo Comparator: Placebo Comparator
Placebo
 Drug: placebo
placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.



Eligibility Criteria
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Ages Eligible for Study:   35 Years to 58 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 35-58 years of age
  2. 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.
  3. Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.
  4. At least one menstrual period within 12 months of study enrollment
  5. Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.
  6. Ability to understand, speak, read and write English.
  7. 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:

  1. VMS without perimenopausal etiology.
  2. Women who have had a hysterectomy and/or ovariectomy.
  3. Peanut allergy (because peanut oil is used in the progesterone formulation.)
  4. 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.
  5. Planned pregnancy or fertility treatment during the study period.
  6. Women who are breastfeeding.
  7. 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.
Contacts and Locations
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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): NCT01464697


Locations
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
Principal Investigator: Jerilynn C Prior, MD FRCPC University of British Columbia
More Information
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Additional Information:
Centre for Menstrual Cycle and Ovulation Research  This link exits the ClinicalTrials.gov site

Publications:
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.

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