Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome (NCT03152591) | Clinical Trial Compass
CompletedPhase 2
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
United States, Germany29 participantsStarted 2017-07-24
Plain-language summary
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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* 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
What they're measuring
1
Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline