Menopause Urological and Genital Diseases Menopausal and other perimenopausal disorders
Conditions
Interventions
The women in this 4-month study are randomised to either the placebo or the oral micronised progesterone. The participants maintain a Daily Menopause Diary© during the period of the study to keep trac
Sponsors
Centre for Menstrual Cycle and Ovulation Research (CeMCOR) (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women past menopause who are between one and ten years of their last menstrual period, not on any hormones for at least the past 6 months, experiencing hot flushes or night sweats and without any history or risk factors of heart disease (smoking, overweight, high lipid levels).
Exclusion criteria
Exclusion criteria: Amendment to protocol as of 17/05/2006: 1. Any menstruation in the preceding year 2. History of hysterectomy without ovariectomy unless she is 60 years of age 3. Use of ovarian hormone therapy (estrogen, progestin, progesterone or androgen) in the preceding six months 4. Any risk factors for heart disease like smoker, high blood pressure, high cholesterol, diabetes, overweight, and history of angina or abnormal electrocardiogram (ECG)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 13/05/2009: Vasomotor symptoms prospectively recorded during the first month compared with changes in months one, two, three and four of the trial Previous primary outcome measures: 1. Vasomotor symptoms prospectively recorded during the first month compared with changes in months one, two, three and four of the trial 2. Forearm blood flow by plethysmography prospectively measured before and after three months of Oral micronised progesterone or placebo therapy 3. Clotting factors, fasting lipids, blood pressure, waist circumference and weight; these changes by Oral micronised progesterone and placebo will provide new and important therapy effects 4. Hormone-related and general quality of life measures using the standardised Menopause-Specific Quality of Life Scale, the SF-36 instrument and Daily Menopause Diary items related to sleep, mood and energy 5. Other cardiovascular markers including C-Reactive Protein (CRP) and Apolipoprotein B (ApoB) | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 13/05/2009: 1. Forearm blood flow by plethysmography prospectively measured before and after three months of Oral micronised progesterone or placebo therapy 2. Clotting factors, fasting lipids, blood pressure, waist circumference and weight; these changes by Oral micronised progesterone and placebo will provide new and important therapy effects 3. Hormone-related and general quality of life measures using the standardised Menopause-Specific Quality of Life Scale, the SF-36 instrument and Daily Menopause Diary items related to sleep, mood and energy 4. Other cardiovascular markers including C-Reactive Protein (CRP) and Apolipoprotein B (ApoB) | — |
Countries
Canada
Outcome results
None listed