NCT01051024已完成3 期
Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Normalization of blood concentrations of androgens at week 24
研究概览
简要总结
The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Two of the following criteria:
- •Oligo or Anovulation
- •Polycystic Ovary diagnosed by ultrasound technique
- •Clinical signs of Hyperandrogenism
- •Signed informed consent
排除标准
- •Personal history of other causes of hyperandrogenism: Hyperprolactinemia, suprarenal tumors, ovary tumors, suprarenal hyperplasia, hypercortisolism.
- •Patients under other experimental treatment
- •Treatment with ovulation inducers and/or insulin sensitizers within 60 days before treatment
- •Treatment with vitamins within 7 days before treatment
- •Treatment with dietary supplements within 60 days before treatment
- •Non-compensated intercurrent diseases: diabetes mellitus, thyroid disease, hypertension
结局指标
主要结局
Normalization of blood concentrations of androgens at week 24
时间窗: 24 weeks
Normalization of blood concentrations prolactin at week 24
时间窗: 24 weeks
Normalization of blood concentrations of estrogens at week 24
时间窗: 24 weeks
Normalization of blood concentrations of FSH at week 24
时间窗: 24 weeks
Normalization of blood concentrations of LH at week 24
时间窗: 24 weeks
次要结局
- Regularization of the menstrual cycle at week 24.(24 weeks)
- Reappearance of ovulatory cycles at week 24(24 weeks)
- Normalization of blood concentrations of insulin at week 24(24 weeks)
- Normalization of blood concentrations of cholesterol at week 24(24 weeks)
- Normalization of blood concentrations of triglycerides at week 24(24 weeks)
- Normalization of blood concentrations of glucose at week 24(24 weeks)
- Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.(24 weeks)
研究者
研究点 (2)
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