Polycystic Ovary Syndrome and Liraglutide

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: PCOS; Obesity

Treatments: Drug: metformin; Drug: liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT01899430

20120047

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

metformin

Active Comparator group

Description:

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.

Treatment:

Drug: metformin

liraglutide

Experimental group

Description:

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.

Treatment:

Drug: liraglutide