Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome

• Status: Completed
• Trial end date: 2018-06-25
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Licogliflozin

Criteria

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