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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2011 by University of British Columbia.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

University of British Columbia

ClinicalTrials.gov Identifier:

NCT00152438

First received: September 8, 2005

Last updated: September 20, 2011

Last verified: September 2011

History of Changes

Purpose

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	Intervention	Phase
Menopause	Drug: Oral Micronized Progesterone (Prometrium®) Other: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Vasomotor Symptoms and Endothelial Function—A Randomized Placebo-controlled Trial of Oral Micronized Progesterone (Prometrium®)

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Progesterone

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Forearm blood flow by plethysmography prospectively measured before and after three months of therapy [ Time Frame: Four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Lipid, blood pressure (BP), waist circumference and weight changes, measured at baseline and at the end of the study period [ Time Frame: Four months ] [ Designated as safety issue: No ]


Estimated Enrollment:	125
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2012
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any menstruation in the preceding year.
History of hysterectomy without ovariectomy unless 60 years of age.
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.
Body mass index (BMI) over 35 or less than 20.
Mean of several pre-treatment blood pressures over 145/95.
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152438

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

Additional Information:

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

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
Study First Received:	September 8, 2005
Last Updated:	September 20, 2011
Health Authority:	Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 26, 2016

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