NCT03152591已完成2 期
A Randomized, Subject- and Investigator-blinded, Placebo-controlled Pharmacodynamic Study of Oral LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
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
- 29
- 试验地点
- 1
- 主要终点
- Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline
研究概览
简要总结
The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •PCOS (diagnosed as clinical or biochemical hyperandrogenism, amenorrhea or oligomenorrhea and exclusion of other causes of hyperandrogenism.
- •Overweight/obese female subjects with BMI of 28 - 45 kg/m^2, inclusive, and stable weight +/- 3 kg over previous 3 months
- •Subjects must use non-hormonal methods of contraception during the study.
排除标准
- •Subjects with exogenous causes of hirsutism
- •Menstruation in the 30 days prior to screening or treatment
- •Pregnant or nursing (lactating) women
- •Use of prohibited medications
- •Preexisting medical condition which may significantly alter the absorption, metabolism, or excretion of the study drug, or which may jeopardize the subject in case of participation in the study
研究组 & 干预措施
LIK066
Experimental
LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
干预措施: LIK066 (Drug)
Placebo
Placebo Comparator
Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline
时间窗: Baseline, Day 15
次要结局
- Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15(Baseline, Day 15)
- Change From Baseline in Luteinizing Hormone (LH) at Day 15(Baseline, Day 15)
- Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15(Baseline, Day 15)
- Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15(Baseline, Day 15)
- Change From Baseline in Free Androgen Index (FAI), at Day 15(Baseline, Day 15)
- Change From Baseline in Androstenedione at Day 15(Baseline, Day 15)
- Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15(Baseline, Day 15)
- Change From Baseline in Total Testosterone, at Day 15(Baseline, Day 15)
研究者
研究点 (1)
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