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

NCT00152438 | Unknown Phase 2

• 1 other identifier: C03-0088
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

Vasomotor symptoms; Menopause

Outcome Measures

Primary Outcomes (2)

• Vasomotor symptoms prospectively recorded in the final month of therapy by therapy assignment, with pre-therapy baseline vasomotor symptoms as a covariate.

  Four months

• Forearm blood flow by plethysmography prospectively measured before and after three months of therapy

  Four months

Secondary Outcomes (3)

• 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

• 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

• Lipid, blood pressure (BP), waist circumference and weight changes, measured at baseline and at the end of the study period

  Four months

Study Arms (2)

1

EXPERIMENTAL

Oral micronized progesterone

Drug: Oral Micronized Progesterone (Prometrium®)

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Oral Micronized Progesterone (Prometrium®) DRUG

300 mg per day in 3 - 100 mg pills, to be taken in the evening immediately before sleep.

Also known as: Oral micronized progesterone: Prometrium®, Uteroestan®

1

Placebo OTHER

3 identical placebo pills daily, no active ingredient.

2

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Centre for Menstrual Cycle and Ovulation Research

Vancouver, British Columbia, Canada

Location

Related Publications (3)

• 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.

  PMID: 24465425 DERIVED

• 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.

  PMID: 23252963 DERIVED

• 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.

  PMID: 22453200 DERIVED

Related Links

• Centre for Menstrual Cycle and Ovulation Research

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Jerilynn Prior

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: September 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2012
• Last Updated: September 22, 2011

Record last verified: 2011-09

Locations

CA (1)