Vasomotor Symptoms and Endothelial Function-A Randomized Placebo-controlled Trial of Oral Micronized Progesterone (Prometrium®)
试验速览
- 阶段
- 2 期
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Vasomotor symptoms prospectively recorded in the final month of therapy by therapy assignment, with pre-therapy baseline vasomotor symptoms as a covariate.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •Mean of several pre-treatment blood pressures over 145/
- •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.
研究组 & 干预措施
1
Oral micronized progesterone
干预措施: Oral Micronized Progesterone (Prometrium®) (Drug)
2
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Vasomotor symptoms prospectively recorded in the final month of therapy by therapy assignment, with pre-therapy baseline vasomotor symptoms as a covariate.
时间窗: Four months
Forearm blood flow by plethysmography prospectively measured before and after three months of therapy
时间窗: Four months
次要结局
- Lipid, blood pressure (BP), waist circumference and weight changes, measured at baseline and at the end of the study period(Four months)
- 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)