Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total Anti-oxidant Capacity
研究概览
简要总结
The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone metabolism parameters are evaluated before and after therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hypotalamic Amenorrhea
排除标准
- •diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
- •hypertension
- •significant liver or renal impairment
- •other hormonal dysfunction (hypothalamic, pituitary, PCOS, thiroidal or adrenal)
- •neoplasms
研究组 & 干预措施
Hormonal Replace Therapy
1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months
干预措施: 1 mg of transdermal estradiol daily and 10mg of oral MPA (Drug)
结局指标
主要结局
Total Anti-oxidant Capacity
时间窗: 6 Month
次要结局
- Osteocalcin(6 Months)
- Bone Mineral Density(6 Months)
- Estrogen levels(6 Months)
- beta crosslaps(6 months)
- number of Cycles in 6 months(6 Months)
研究者
Rosanna Apa
Professor
Catholic University of the Sacred Heart