NCT02663570Unknown不适用
Effects of 6 Months of Melatonin Treatment on Clinical, Endocrine ed Metabolic Features in Women Affected by PCOS
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of cycles in six months of therapy
研究概览
简要总结
The aim of our study is to investigate the effects of a treatment with melatonin on clinical, endocrine and metabolic features in women affected by PCOS. The study group included 40 patients treatend with 2 mg of melatonin daily for six months. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian volume and antral follicular count, an oral glucose tollerance test and hormonal assays 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
- •women with PCOS in accordance with Rotterdam criteria
排除标准
- •pregnancy
- •past history of cardiovascular diseases
- •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, thiroidal or adrenal)
- •neoplasms
研究组 & 干预措施
open
Experimental
therapy with melatonin 2 mg daily for six months
干预措施: Melatonin (Drug)
结局指标
主要结局
Number of cycles in six months of therapy
时间窗: 6 months
次要结局
- free androgen index(6 months)
- insulin levels(6 months)
- tryglycerides(6 months)
- hirsutism score(6 months)
- LDL cholesterol(6 months)
- androstenedione levels(6 months)
- AMH levels(6 months)
- testosterone levels(6 months)
- total cholesterol(6 months)
- HDL cholesterol(6 months)
研究者
Rosanna Apa
Professor
Catholic University of the Sacred Heart
研究点 (1)
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