UnknownPhase 2

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

Canada125 participantsStarted 2005-09

Plain-language 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.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Four months

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

Timeframe: Four months

Trial details

NCT IDNCT00152438

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-10

View on ClinicalTrials.gov More Menopause trials

Plain-language summary

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Four months

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

Timeframe: Four months