PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome | RxWiki

PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

Overview[ - collapse ][ - ]

Purpose	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.
Condition	PCOS Obesity
Intervention	Drug: metformin Drug: metformin and roflumilast
Phase	Phase 4
Sponsor	University Medical Centre Ljubljana
Responsible Party	University Medical Centre Ljubljana
ClinicalTrials.gov Identifier	NCT02037672
First Received	January 14, 2014
Last Updated	January 21, 2014
Last verified	January 2014

Tracking Information[ + expand ][ + ]

First Received Date	January 14, 2014
Last Updated Date	January 21, 2014
Start Date	September 2013
Estimated Primary Completion Date	January 2014
Current Primary Outcome Measures	The main outcome was change in body weight. [Time Frame: Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.] [Designated as safety issue: No]The patient's body weight was measured in kilograms.
Current Secondary Outcome Measures	The secondary outcome was change in body mass index (BMI). [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.] [Designated as safety issue: No]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. [Time Frame: Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.] [Designated as safety issue: No]Patient's waist circumference was measured in centimeters.

Descriptive Information[ + expand ][ + ]

Brief Title	PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome
Official Title	Combined Treatment With PDE-4 Inhibitor Roflumilast and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome
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 Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	PCOS Obesity
Intervention	Drug: metformin Other Names: Glucophage tabletsDrug: metformin and roflumilast Other Names: Glucophage tablets and Daxas 500 micrograms film-coated tablets
Study Arm (s)	Active Comparator: 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. Active Comparator: 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	36
Estimated Completion Date	January 2014
Estimated Primary Completion Date	December 2013
Eligibility Criteria	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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Slovenia

Administrative Information[ + expand ][ + ]

NCT Number	NCT02037672
Other Study ID Numbers	DAXAS
Has Data Monitoring Committee	No
Information Provided By	University Medical Centre Ljubljana
Study Sponsor	University Medical Centre Ljubljana
Collaborators	Not Provided
Investigators	Principal Investigator: Andrej Janez, MD, PhD University Medical Centre Ljubljana
Verification Date	January 2014

Locations[ + expand ][ + ]