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临床试验/NCT00151411
NCT00151411已完成2 期

The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2004年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Metformin

干预措施: Metformin (Drug)

Metformin

Experimental

Metformin

干预措施: Lifestyle Intervention (Behavioral)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard S. Legro, M.D.

Professor, Obstetrics and Gynecology and Public Health Sciences

Milton S. Hershey Medical Center

研究点 (1)

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