The Effect of Cipralex in Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).
Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.
详细描述
We want to investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).
PCOS is characterized by menstrual deregulation, high testosterone, mail hair growth and increased stress hormones from the adrenals. Furthermore there are changes similar to those seen in diabetes.
Cipralex is known to decrease stress hormones. But no investigations are on the effect of cipralex on PCOS, or how the increased stress hormones affect the PCOS condition.
We will examine 2x20 women with PCOS. They will be randomized to Cipralex or placebo. Treatment duration is 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI >25 and <50
- •Age < 50
排除标准
- •Epilepsia
- •use of metformin or oral anticonceptives
- •pregnancy/breastfeeding
研究组 & 干预措施
active comparator
Drug: Cipralex
干预措施: Cipralex (Drug)
placebo comparator
Drug: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Quality of Life
时间窗: 14 weeks
Measured by questionaires
次要结局
- Level of cortisone in 24 hour urine sample(June 2013 to October 2015)
研究者
Marianne Andersen
Professor, chief physisian
Odense University Hospital