NCT02037672

PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

Combined Treatment With PDE-4 Inhibitor Roflumilast and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PCOS
• Obesity

Interventions

Type	Name	Description
DRUG	metformin
DRUG	metformin and roflumilast

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2014-01-16
• Last updated: 2014-01-22

Locations

1 site across 1 country: Slovenia