Status:

COMPLETED

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

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 monotherapy treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with glucagon-like protein 1 (GLP-1) li...

Eligibility Criteria

Inclusion

  • 18 years old to menopause
  • polycystic ovary syndrome (NICHD criteria)
  • BMI of 30 kg/m² or higher

Exclusion

  • 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

Key Trial Info

Start Date :

March 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT02187250

Start Date

March 1 2014

End Date

June 1 2014

Last Update

July 10 2014

Active Locations (1)

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University Medical Center Ljubljana

Ljubljana, Slovenia, 1000