Polycystic Ovary Syndrome and Liraglutide

NCT ID: NCT01899430

Last Updated: 2013-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-04-30

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.

Detailed Description

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Conditions

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PCOS Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin

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.

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

liraglutide

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.

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Interventions

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liraglutide

Intervention Type DRUG

metformin

Intervention Type DRUG

Other Intervention Names

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Victoza 6 mg/ml solution for injection in pre-filled pen Glucophage tablets

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Andrej Janez

professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrej Janez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

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University Medical Center Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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20120047

Identifier Type: -

Identifier Source: org_study_id

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