NCT00236301终止3 期
Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Hs-C-reactive protein
研究概览
简要总结
Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.
详细描述
Pro-inflammatory study of the effects in short term of two difference doses of 17beta-estradiol at the menopause woman
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptomatic menopausal women : >=50 years and amenorrhea >=1 year or <50 years and amenorrhea >=1 year and plasmatic FSH >= 30 UI/l
- •Normal mammography in the last 2 years before inclusion
- •Normal cervical smear in the last 2 years before inclusion
- •Written consent for participation in the study
排除标准
- •Unconfirmed Menopause with amenorrhoea of less than year
- •Oestrogen-progesterone Treatment anterior in 3 months previous the inclusion
- •Recently a viral Infection or bacteriologic(at least of 2 weeks)
- •Dental Infection
- •Inflammatory Pathology chronicles
- •Antecedent of pathology cancerous with or no a sly hemopathy
- •Addiction to smoking of more than 20 cigarettes a day or an alcoholic consumption furthermore of 4 glasses a day
- •Taken concomitant of one of the treatments forbidden:statine, vitamin B6 or B12, folates, antiinflammatory, anti aggregant Plaquettes, DHEA, phytoestrogens
- •Refusal to sign the assent informed
- •Not membership in a regime about social security
研究组 & 干预措施
1
Active Comparator
17 Beta-estradiol (2mg/day)and (1mg/day)
干预措施: 17 Beta-estradiol (2mg/day)and (1mg/day) (Drug)
2
Active Comparator
CLIMASTON
干预措施: CLIMASTON (drug) (Drug)
3
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Hs-C-reactive protein
时间窗: 2 months
次要结局
- Interleukin (IL-6, IL-18, IL-10), TNF-alpha, apoptotic microparticles, homocysteine, total cholesterol/HDL cholesterol, Lp(a), interleukin 6, ICAM soluble,(2 months)
- Eslectin, prothrombin F1+2, factor VIII, resistance to activated protein C (RPCA or ACV test),IL 18, IL10, IL8(2 months)
研究者
研究点 (1)
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