Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 2/24/2019 |
| Start Date: | July 24, 2017 |
| End Date: | June 25, 2018 |
A Randomized, Subject- and Investigator-blinded, Placebo-controlled Pharmacodynamic Study of Oral LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
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.
polycystic ovary syndrome (PCOS) in overweight and obese women.
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
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