Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than liraglutide or 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. We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with liraglutide or metformin.

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

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Liraglutide; Metformin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 18 years old to menopause

• polycystic ovary syndrome (NICHD criteria)

• BMI of 30 kg/m² or higher

• poor response to previous treatment with metformin for at least 3 months

Exclusion Criteria:

• type 1 or type 2 diabetes mellitus

• history of carcinoma

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

• personal or family history of MEN 2

• significant cardiovascular, kidney or hepatic disease

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

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