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

Menopause Clinical Trial

Official title:

Vasomotor Symptoms and Endothelial Function—A Randomized Placebo-controlled Trial of Oral Micronized Progesterone (Prometrium®)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00152438
• Other study ID #: C03-0088
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: September 20, 2011
• Start date: September 2005
• Est. completion date: December 2012

Study information

• Verified date: September 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: December 2012
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Oral Micronized Progesterone (Prometrium®)
300 mg per day in 3 - 100 mg pills, to be taken in the evening immediately before sleep.

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

Locations

Country	Name	City	State
Canada	Centre for Menstrual Cycle and Ovulation Research	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasomotor symptoms prospectively recorded in the final month of therapy by therapy assignment, with pre-therapy baseline vasomotor symptoms as a covariate.		Four months	No
Primary	Forearm blood flow by plethysmography prospectively measured before and after three months of therapy		Four months	No
Secondary	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.		Four months	No
Secondary	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		Four months	No
Secondary	Lipid, blood pressure (BP), waist circumference and weight changes, measured at baseline and at the end of the study period		Four months	No

External Links

•   Centre for Menstrual Cycle and Ovulation Research