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Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms

This study is currently recruiting participants.
Verified February 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01464697
First received: October 31, 2011
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to test whether a oral micronized progesterone reduces the score, 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 problems, mood and health-related quality of life.


Condition Intervention Phase
Hot Flushes
Night Sweats
 Drug: Oral micronized progesterone
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Vasomotor Symptoms (VMS)/ VMS Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Participants will complete a daily diary (Daily Perimenopause Diary; www.cemcor.ubc.ca) 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 175
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Drug: placebo
placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks

Detailed Description:

This is a randomized, 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.

  Eligibility

Ages Eligible for Study:   35 Years to 58 Years
Genders 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. Ability and willingness to complete the Daily Perimenopause Diary recording instrument.
  5. Ability to understand, speak, read and write English.
  6. Normal clinical breast examination within the 12 months of study enrollment (Health Canada requirement).
  7. If over 40, normal mammogram within 12 months of study enrollment (Health Canada requirement).

Exclusion Criteria:

  1. Less than 35 or greater than 58 years of age
  2. No VMS, or VMS not meeting inclusion criteria, or VMS without perimenopausal etiology
  3. More than 1-yr without menstrual flow, including those with a hysterectomy, +/- ovariectomy
  4. Peanut allergy (because peanut oil is used in the progesterone formulation)
  5. Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen, progesterone, progestin-releasing IUD, hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period
  6. Planned pregnancy or fertility treatment during the study period
  7. Inability to understand, speak, read and write English
  8. Women age 40 or older without a normal mammogram within 12 months of study enrollment (Health Canada requirement).
  9. Women who have not had a normal clinical breast examination within 12 months of study enrollment (Health Canada requirement).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464697

Contacts
Contact: Jerilynn C Prior, MD, FRCPC (604) 875-5927 jerilynn.prior@ubc.ca
Contact: Andrea Cameron, RN, BScN (604) 875-5960 andrea.cameron@ubc.ca

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 Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Jerilynn C Prior, MD FRCPC     (604) 875-5927     jerilynn.prior@ubc.ca    
Contact: Andrea Cameron, RN BScN     (604) 875-5960     andrea.cameron@ubc.ca    
Principal Investigator: Jerilynn C Prior, MD FRCPC            
Sub-Investigator: Christine L Hitchcock, PhD            
Sub-Investigator: Shirin Kalyan, PhD            
Sub-Investigator: Patricia Janssen, PhD            
Sub-Investigator: Michelle Fung, MD MHSc FRCPC            
Sub-Investigator: Elana Brief, PhD            
Sub-Investigator: Caroline Ferris, MD, FRCPC            
Sub-Investigator: Joel Singer, PhD            
Sub-Investigator: Sandra Sirrs, MD FRCPC            
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jerilynn C Prior, MD FRCPC University of British Columbia
  More Information

Additional Information:
Centre for Menstrual Cycle and Ovulation Research  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01464697     History of Changes
Other Study ID Numbers: H10-02975
Study First Received: October 31, 2011
Last Updated: February 12, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
hot flushes
night sweats
sleep problems
negative mood
anxiety
 perimenopause
progesterone
vasomotor symptoms
premenopause

Additional relevant MeSH terms:
Flushing
Hot Flashes
Signs and Symptoms
Progesterone
Progestins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013