PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

Phase 4CompletedNCT02037672

University Medical Centre Ljubljana36 enrolled

Overview

The purpose of this study was to determine whether combined treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than 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. The investigators anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with metformin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PCOS Obesity

Interventions

metforminDRUG

metformin and roflumilastDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 * 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

Locations (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

The main outcome was change in body weight.

The patient's body weight was measured in kilograms.

Time frame: Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.

Secondary Outcomes

The secondary outcome was change in body mass index (BMI).

Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.

Time frame: Patient's body weight were measured at the basepoint and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint.

The secondary outcome was change in waist circumference.

Patient's waist circumference was measured in centimeters.

Time frame: Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.

Data from ClinicalTrials.gov

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