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

Information source: University Medical Centre Ljubljana
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: PCOS; Obesity

Intervention: metformin (Drug); liraglutide (Drug); metformin and liraglutide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Medical Centre Ljubljana

Official(s) and/or principal investigator(s):
Andrej Janez, MD PhD, Principal Investigator, Affiliation: University Medical Centre Ljubljana

Summary

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.

Clinical Details

Official title: Short-term Combined Treatment With Liraglutide and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome and Previous Poor Response to Metformin

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The main outcome was change in body weight.

Secondary outcome:

The secondary outcome was change in body mass index (BMI).

The secondary outcome was change in waist circumference.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

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 and Contacts

University Medical Center Ljubljana, Ljubljana 1000, Slovenia
Additional Information

Starting date: November 2011
Last updated: July 26, 2013

Page last updated: August 23, 2015

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