PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

Phase 4

Completed

• Conditions: PCOS; Obesity
• Interventions: Drug: metformin and roflumilast; Drug: metformin

• Registration Number: NCT02037672
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-12
• Status Verified: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin and roflumilast	metformin and roflumilast	In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os. At the same time roflumilast was initiated at a dose of 500 mg BID per os.
metformin	metformin	In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os.

Primary Outcome Measures

Name	Time	Method
The main outcome was change in body weight.	Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.	The patient's body weight was measured in kilograms.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome was change in body mass index (BMI).	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.	Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
The secondary outcome was change in waist circumference.	Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.	Patient's waist circumference was measured in centimeters.

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia