Study of LIK066 in overweight and obese women with polycystic ovary syndrome
- Conditions
- polycystic ovary syndromeMedDRA version: 20.0Level: LLTClassification code 10036050Term: Polycystic ovarySystem Organ Class: 100000004872Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2017-001373-16-DE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 29
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the treatment effect of LIK066 on hyperandrogenism at Day 15 in overweight and obese subjects with PCOS;Secondary Objective: - To assess the safety and tolerability of LIK066 in overweight and obese subjects with PCOS throughout the study.<br>- To evaluate the treatment effect of LIK066 on gonadotropins and sex steroid levels.;Primary end point(s): Change in average morning fasting free testosterone blood concentrations from baseline;Timepoint(s) of evaluation of this end point: Baseline, Day 15
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change from baseline in luteinizing hormone (LH) at Day 15<br>- Change from baseline in follicle stimulating hormone (FSH) at Day 15<br>- Change from baseline in sex hormone binding globulin (SHBG) at Day<br>15<br>- Change from baseline in androstenedione at Day 15<br>- Change from baseline in dehydroepiandrostenedione (DHEA) at Day 15<br>- Change from baseline in dehydroepiandrostenedione sulfate (DHEAS)<br>at Day 15<br>- Change from baseline in total testosterone, at Day 15<br>- Change from baseline in free androgen index (FAI), at Day 15<br>-Adverse events throughout the study, serum electrolytes and<br>hematocrit on Day 15;Timepoint(s) of evaluation of this end point: Baseline, Day 15