PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Combined Treatment With PDE-4 Inhibitor Roflumilast and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome

Conditions
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PCOS, Obesity

Intervention / Treatment
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* Drug: metformin
* Drug: metformin and roflumilast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin<br>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. | Drug: metformin<br> <br> * Other names: Glucophage tablets;|
| Active Comparator: metformin and roflumilast<br>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. | Drug: metformin and roflumilast<br> <br> * Other names: Glucophage tablets and Daxas 500 micrograms film-coated tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome was change in body weight. | The patient's body weight was measured in kilograms. | Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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roflumilast, metformin, obesity, PCOS, PDE-4 inhibitor