Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin

Phase 4CompletedNCT01911468

University Medical Centre Ljubljana36 enrolled

Overview

The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than liraglutide or 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. We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with liraglutide or metformin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PCOS Obesity

Interventions

metforminDRUG

liraglutideDRUG

metformin and liraglutideDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years old to menopause * polycystic ovary syndrome (NICHD criteria) * BMI of 30 kg/m² or higher * poor response to previous treatment with metformin for at least 3 months 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

Locations (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

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.

The secondary outcome was change in waist circumference.

Patient's waist circumference was measured in centimeters.

Time frame: Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.

Data from ClinicalTrials.gov

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