Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome

University Medical Centre Ljubljana40 enrolled

Overview

The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PCOS Obesity

Interventions

MetforminDRUG

Glucophage tablets and VictozaDRUG

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 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

Change in body weight

Time frame: up to 12 weeks of clinical trial

The number of good responders to combined treatment regarding body weight

Time frame: up to 12 weeks of clinical trial

Secondary Outcomes

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: up to 12 weeks of clinical trial

Change in waist circumference

waist circumference was measured in centimeters.

Time frame: up to 12 weeks of clinical trial

Data from ClinicalTrials.gov

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