The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Change in Testosterone After 6 Months of Treatment
研究概览
简要总结
The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.
详细描述
PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a variety of non-hospital based populations have provided evidence that the incidence of hyperandrogenic chronic anovulation is in the range of 4-6% of the female population. Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult female population is to determine that combination therapy will improve ovulatory frequency. Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then single agent therapy. The primary objective of the adolescent population is to determine that the combination therapy will improve hyperandrogenemia. Secondary objective is to improve ovulatory frequency and insulin sensitivity than just the use of a single agent therapy.
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
- 12 Years 至 39 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8 or less periods per year
- •Elevated testosterone levels
- •General good health
- •Off of current medications which may confound response to study medications
排除标准
- •Pregnancy
- •Lactose Intolerance
- •Medical Contraindications
- •Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests
- •Diabetes, liver, heart, kidney or uncorrected thyroid disease
研究组 & 干预措施
Metformin
Metformin
干预措施: Metformin (Drug)
Metformin
Metformin
干预措施: Lifestyle Intervention (Behavioral)
Placebo
Placebo
干预措施: Placebo (Drug)
Placebo
Placebo
干预措施: Lifestyle Intervention (Behavioral)
结局指标
主要结局
Change in Testosterone After 6 Months of Treatment
时间窗: baseline and 6 months
次要结局
- Ovulation Rate(6 months)
- Change in Insulin Sensitivity Index After 6 Months of Treatment(baseline and 6 months)
研究者
Richard S. Legro, M.D.
Professor, Obstetrics and Gynecology and Public Health Sciences
Milton S. Hershey Medical Center
