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Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone

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ClinicalTrials.gov Identifier: NCT00152438
Recruitment Status : Unknown
Verified September 2011 by University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2005
Last Update Posted : September 22, 2011
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:

The primary purpose of this study is to determine the effects of a full dose (300 mg at hs) of oral micronized progesterone (OMP) on vasomotor symptoms [VMS] (hot flushes/night sweats), on forearm blood flow and on lipid levels and blood pressure in menopausal women without cardiovascular disease and with moderate to severe VMS.

The hypotheses are that progesterone will improve hot flushes, increase endothelium-dependent forearm blood flow and will decrease blood pressure without change in lipid levels.

Condition or disease Intervention/treatment Phase
Menopause Drug: Oral Micronized Progesterone (Prometrium®) Other: Placebo Phase 2

Detailed Description:

In this 4-month study, menopausal women are randomized to either placebo or oral micronized progesterone (Prometrium®). Participants maintain a daily diary to keep track of their vasomotor symptoms and other factors. Forearm blood flow will be assessed by venous occlusion plethysmography at baseline and after three months of therapy. Screening tests at baseline to rule out heart disease include measurement of blood pressure and heart rate, electrocardiogram (ECG) and blood tests - fasting blood glucose and lipid profile.

Collection of serum and plasma samples at baseline and end of therapy for analysis of cardiovascular markers (e.g., c-reactive protein) and clotting and fibrinolytic markers. Continued daily diary collection for one month after therapy discontinuation to look for possible rebound effects. Analysis of outcomes will be by analysis of covariates, with final value as the outcome, therapy as factor and baseline values as covariate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Vasomotor Symptoms and Endothelial Function-A Randomized Placebo-controlled Trial of Oral Micronized Progesterone (Prometrium®)
Study Start Date : September 2005
Actual Primary Completion Date : October 2009
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Oral micronized progesterone
Drug: Oral Micronized Progesterone (Prometrium®)
300 mg per day in 3 - 100 mg pills, to be taken in the evening immediately before sleep.
Other Name: Oral micronized progesterone: Prometrium®, Uteroestan®

Placebo Comparator: 2
Other: Placebo
3 identical placebo pills daily, no active ingredient.

Primary Outcome Measures :
  1. Vasomotor symptoms prospectively recorded in the final month of therapy by therapy assignment, with pre-therapy baseline vasomotor symptoms as a covariate. [ Time Frame: Four months ]
  2. Forearm blood flow by plethysmography prospectively measured before and after three months of therapy [ Time Frame: Four months ]

Secondary Outcome Measures :
  1. Other hormone-related quality of life measures on the Daily Menopause Diary®, especially self worth, sleep, and energy, recorded during the 4 months of the study. [ Time Frame: Four months ]
  2. Changes in two Quality of Life instruments - the Rand SF-36 and the Menopause-specific Quality of Life (MenQoL) questionnaires, measured at baseline and at the end of the study period [ Time Frame: Four months ]
  3. Lipid, blood pressure (BP), waist circumference and weight changes, measured at baseline and at the end of the study period [ Time Frame: Four months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Menopausal women (final menstrual period one or more but less than 10 years before)
  2. No evidence of vascular disease (normal BP; without diabetes mellitus; normal cholesterol levels and non-smoker for at least a year; and normal ECG.)
  3. Moderate to severe VMS during the day and night.

Exclusion Criteria:

  1. Any menstruation in the preceding year.
  2. History of hysterectomy without ovariectomy unless 60 years of age.
  3. Use of ovarian hormone therapy (estrogen, progestin, progesterone or androgen) or selective estrogen receptor modulator (SERM) therapy (raloxifene or tamoxifen) in the preceding six months.
  4. Body mass index (BMI) over 35 or less than 20.
  5. Mean of several pre-treatment blood pressures over 145/95.
  6. Documented abnormal cholesterol; abnormal fasting capillary glucose; abnormal angiogram; ECG or exercise stress tests or a diagnosis of diabetes mellitus; or any history suggestive of angina.

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): NCT00152438

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Canada, British Columbia
Centre for Menstrual Cycle and Ovulation Research
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Jerilynn Prior University of British Columbia
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00152438    
Other Study ID Numbers: C03-0088
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011
Keywords provided by University of British Columbia:
Vasomotor symptoms
Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs