drugset / Trial / NCT02037672
PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2013-09
- Primary completion
- 2013-12
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 1000 mg | Oral |
| Comparator | Roflumilast | Small molecule | 500 mg | Oral |