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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

Tracking Information
First Submitted Date  ICMJE October 31, 2011
First Posted Date  ICMJE November 3, 2011
Last Update Posted Date May 9, 2017
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
Vasomotor Symptoms (VMS)/ VMS Score [ Time Frame: 12 weeks ]
Participants will complete a daily diary (Daily Menopause Diary) 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.
Change History Complete list of historical versions of study NCT01464697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
  • Frequency of VMS [ Time Frame: 12 weeks ]
    Frequency (count) of hot flushes and night sweats per day from prospective daily diary 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 and night sweats per day from prospective daily diary 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 [ Time Frame: 12 weeks ]
    Daily average rating of sleep problems (0-4) from prospective daily diary 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.
  • Mood [ Time Frame: 12 weeks ]
    Daily average rating of mood, computed from prospective daily diary records. Mood (0-12) is the sum of three items: frustration, anxiety, depression, each rated 0-4. Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
  • Health-related Quality of Life [ Time Frame: 12 weeks ]
    Medical Outcomes Study Health Survey (36 item short form, version 1) SF-36, in particular the Vitality subscale. Questionnaire will be completed prior to randomization and at the end of therapy. Analysis will be by analysis of covariance, with baseline response as a covariate.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
Official Title  ICMJE Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hot Flushes
  • Night Sweats
Intervention  ICMJE
  • Drug: Oral micronized progesterone
    300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
    Other Names:
    • Prometrium
    • Utrogestan
  • Drug: placebo
    placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
Study Arms  ICMJE
  • Experimental: oral micronized progesterone
    Oral micronized progesterone is Prometrium 300 mg at bedtime daily
    Intervention: Drug: Oral micronized progesterone
  • Placebo Comparator: Placebo Comparator
    Placebo
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 9, 2016)
249
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2011)
175
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 58 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01464697
Other Study ID Numbers  ICMJE H10-02975
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jerilynn Prior, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jerilynn C Prior, MD FRCPC University of British Columbia
PRS Account University of British Columbia
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP