Status:

COMPLETED

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

Lead Sponsor:

University Medical Centre Ljubljana

Conditions:

PCOS

Obesity

Eligibility:

FEMALE

18-55 years

Phase:

PHASE4

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2013

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT01911468

Start Date

November 1 2011

End Date

April 1 2013

Last Update

July 30 2013

Active Locations (1)

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University Medical Center Ljubljana

Ljubljana, Slovenia, 1000