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

NCT02187250 · Completed

Last updated 2026-05-28

This clinical trial tested whether the medications roflumilast and liraglutide could help reduce body weight in women with polycystic ovary syndrome (PCOS) and obesity.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 45 people

Who can join Ages 18–55 · female only

Timeline Started 2014-03 · est. completion 2014-06

Where 1 site · Slovenia

What this study is testing ClinicalTrials.gov NCT02187250 ↗

Description as written by the study sponsor.

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.

Treatments tested

metformin also known as Glucophage tablets Drug
liraglutide also known as Victoza injection Drug
roflumilast also known as Daxas 500 micrograms film-coated tablets Drug

Main thing measured	The main outcome was change in body weight.
Sponsor	University Medical Centre Ljubljana
Conditions studied	PCOS, Obesity
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02187250 ↗