drugset / Trial / NCT02037672

PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

NCT02037672

Phase 4 Completed 36 enrolled University Medical Centre Ljubljana
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

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg Oral
Comparator Roflumilast Small molecule 500 mg Oral