EUCTR2017-001373-16-DE
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- polycystic ovary syndrome
- Sponsor
- ovartis Pharma AG
- Enrollment
- 29
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
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.
- •\- See further details on protocol.
Outcomes
Primary Outcomes
Not specified
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