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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Liraglutide; Metformin; Phosphodiesterase 4 Inhibitors

Criteria

Inclusion Criteria:

• 18 years old to menopause

• polycystic ovary syndrome (NICHD criteria)

• BMI of 30 kg/m² or higher

Exclusion Criteria:

• depression

• type 1 or type 2 diabetes mellitus

• history of carcinoma

• history of pancreatitis

• Cushing's syndrome or congenital (non-classic) adrenal hyperplasia

• significant cardiovascular, kidney or hepatic disease

• the use of medications other than metformin known or suspected to affect reproductive or metabolic functions

• the use of statins, within 90 days prior to study entry