Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy: A Randomized, Placebo-controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Vascular function
研究概览
简要总结
Recent large randomized, placebo-controlled studies assessing the health effects of HT question the overall benefits of long term HT, especially with respect to cardiovascular disease. However, recently menopausal women with severe hot flushes were mostly excluded from these trials. This was unfortunate since vasomotor symptoms may reflect different vascular sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in women with and without hot flushes can differ.
Aims of the present project are
- to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms
- in a randomized placebo controlled clinical trial investigate vascular response to oral and trans-dermal HT.
详细描述
We recruit 160 healthy postmenopausal women between ages 48-55. Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas 80 comparators must be symptomless (no hot flushes). Thorough vascular function and risk factor assessments will be done, including clinical assessment of autonomic nervous system, endothelial function measurements, 24-hour ECG and blood pressure evaluation, and lipid and various other vascular surrogate marker measurements. In the first part of the study we compare these baseline measurements between women with or without severe vasomotor symptoms. In the second part of the study the women are randomized to receive placebo, oral estrogen, oral estrogen plus progestin or transdermal estrogen for 6 months. After the treatments the baseline assessments are repeated.
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
- 48 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women between ages 48-55
- •Minimum of 6 months and maximum of 36 months from last menstrual period
- •Postmenopausal status of these women will be confirmed by level of FSH that should exceed 30 U/l
- •Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas eighty comparators must be symptomless
排除标准
- •hysterectomy
- •dyslipidemia
- •overt hypertension (blood pressure > 140/90)
- •any regular medication
- •HT in the previous 3 months
- •body mass index over 27
研究组 & 干预措施
1
Postmenopausal women without vasomotor symptoms
干预措施: 17-b-estradiol + medroxyprogeterone acetate (Drug)
2
Postmenopausal women with severe vasomotor symptoms
干预措施: 17-b-estradiol (Drug)
2
Postmenopausal women with severe vasomotor symptoms
干预措施: 17-b-estradiol + medroxyprogeterone acetate (Drug)
2
Postmenopausal women with severe vasomotor symptoms
干预措施: 17-b-estradiol hemihydrate (Drug)
2
Postmenopausal women with severe vasomotor symptoms
干预措施: placebo pill + gel (Drug)
1
Postmenopausal women without vasomotor symptoms
干预措施: 17-b-estradiol (Drug)
1
Postmenopausal women without vasomotor symptoms
干预措施: 17-b-estradiol hemihydrate (Drug)
1
Postmenopausal women without vasomotor symptoms
干预措施: placebo pill + gel (Drug)
结局指标
主要结局
Vascular function
时间窗: 0 and 6 months
次要结局
- Cardiac and sympathetic function(0 and 6 months)
研究者
Tomi S. Mikkola
Associate Professor
University of Helsinki