Polycystic Ovary Syndrome and Liraglutide
- Sponsor
- University Medical Centre Ljubljana
- Study ID
- NCT01899430
- Phase
- PHASE4
- Status
- Completed
Conditions
- Obesity
- PCOS
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- liraglutide — DRUG
- metformin — DRUG
Study Details
The purpose of this study was to determine whether liraglutide is more effective than metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide than in those treated with metformin.
Key Dates
- Start date
- Nov 30, 2011
- Status verified
- Jul 2013
- Primary completion
- Oct 31, 2012
- Completion
- Apr 30, 2013
Study Design
- Enrollment
- 32 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: metforminIn the MET group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os.
- Experimental: liraglutideIn the LIRA group liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week.
Primary Outcome Measure
The main outcome was change in body weight. [ Time Frame: Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial. ]
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