EUCTR2017-001373-16-DE进行中（未招募）1 期
A randomized, subject- and investigator-blinded, placebo-controlled pharmacodynamic study of oral LIK066 in overweight and obese women with polycystic ovary syndrome - Study of pharmacodynamics of LIK066 in overweight and obese women with polycystic ovary syndrome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- PCOS (diagnosed as clinical or biochemical hyperandrogenism, amenorrhea or oligomenorrhea and exclusion of other causes of hyperandrogenism.
- •- Overweight/obese subjects with BMI equal to or > 27 kg/m^2, and stable weight +/- 3 kg over previous 3 months
- •- Subjects must use non-hormonal methods of contraception during the study.
- •- See further details on protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
- •- See further details on protocol.
研究者
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