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

Study Description

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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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Locations

Canada, British Columbia
Centre for Menstrual Cycle and Ovulation Research
Vancouver, British Columbia, Canada

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:	Jerilynn Prior	University of British Columbia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Centre for Menstrual Cycle and Ovulation Research 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Prior JC, Elliott TG, Norman E, Stajic V, Hitchcock CL. Progesterone therapy, endothelial function and cardiovascular risk factors: a 3-month randomized, placebo-controlled trial in healthy early postmenopausal women. PLoS One. 2014 Jan 21;9(1):e84698. doi: 10.1371/journal.pone.0084698. eCollection 2014.

Sathi P, Kalyan S, Hitchcock CL, Pudek M, Prior JC. Progesterone therapy increases free thyroxine levels--data from a randomized placebo-controlled 12-week hot flush trial. Clin Endocrinol (Oxf). 2013 Aug;79(2):282-7. doi: 10.1111/cen.12128. Epub 2013 May 6.

Hitchcock CL, Prior JC. Oral micronized progesterone for vasomotor symptoms--a placebo-controlled randomized trial in healthy postmenopausal women. Menopause. 2012 Aug;19(8):886-93. doi: 10.1097/gme.0b013e318247f07a.

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00152438 History of Changes
Other Study ID Numbers:	C03-0088
First Posted:	September 9, 2005
Last Update Posted:	September 22, 2011
Last Verified:	September 2011

Keywords provided by University of British Columbia:

Vasomotor symptoms; Menopause

Additional relevant MeSH terms:

Progesterone; Progestins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs