Polycystic Ovary Syndrome and Liraglutide

Study Overview
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Brief Summary
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The purpose of this study was to determine whether liraglutide is more effective than metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide than in those treated with metformin.

Official Title
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Short-term Liraglutide Treatment in Obese Women With Polycystic Ovary Syndrome

Conditions
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PCOS, Obesity

Intervention / Treatment
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* Drug: liraglutide
* Drug: metformin


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: type 1 or type 2 diabetes mellitus history of carcinoma Cushing's syndrome or congenital (non-classic) adrenal hyperplasia personal or family history of MEN 2 significant cardiovascular, kidney or hepatic disease the use of medications 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 MET 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;|
| Experimental: liraglutide<br>In the LIRA group liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week. | Drug: liraglutide<br> <br> * Other names: Victoza 6 mg/ml solution for injection in pre-filled pen;|

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. |  | 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 base point 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, obesity, GLP-1 receptor agonist, liraglutide, metformin