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Combined Treatment With PDE-4 Inhibitor Roflumilast and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome
The purpose of this study was to determine whether combined treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. The investigators anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with metformin.
Details
| Lead sponsor | University Medical Centre Ljubljana |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2013-09 |
| Completion | 2014-01 |
Conditions
- PCOS
- Obesity
Interventions
- metformin
- metformin and roflumilast
Primary outcomes
- The main outcome was change in body weight. — Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.
The patient's body weight was measured in kilograms.
Countries
Slovenia