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

Study Overview
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Brief Summary
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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.

Official Title
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Short-term Treatment With PDE-4 Inhibitor Roflumilast or GLP-1 Agonist Liraglutide or Metformin in Treatment Naive Obese Women With Polycystic Ovary Syndrome

Conditions
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PCOS, Obesity

Intervention / Treatment
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* Drug: metformin
* Drug: liraglutide
* Drug: 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 history of pancreatitis 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 2x1000 mg BID per os. | Drug: metformin<br> <br> * Other names: Glucophage tablets;|
| Active Comparator: liraglutide<br>In the liraglutide group liraglutide was initiated at a dose of 0,6mg sc once per day for one week and increased to 1,2mg sc one per day. | Drug: liraglutide<br> <br> * Other names: Victoza injection;|
| Active Comparator: roflumilast<br>In the roflumilast group roflumilast was initiated at a dose of 500 mg BID per os. | Drug: roflumilast<br> <br> * Other names: 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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PCOS, PDE-4 inhibitor, roflumilast, liraglutide, metformin, obesity