drugset / Trial / NCT02187250

PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

NCT02187250

Phase 4 Completed 45 enrolled University Medical Centre Ljubljana
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to determine whether monotherapy treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with glucagon-like protein 1 (GLP-1) liraglutide or treatment with metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding weight reduction who have not been treated before. The investigators anticipated greater changes in body weight in patients on roflumilast treatment than in liraglutide or metformin.

Timeline

Start
2014-03
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Liraglutide Peptide 1.2 mg Subcutaneous
Comparator Metformin Small molecule 1000 mg Oral
Comparator Roflumilast Small molecule 500 mg Oral