Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | PCOS Obesity |
Intervention | Drug: metformin Drug: liraglutide Drug: metformin and liraglutide |
Phase | Phase 4 |
Sponsor | University Medical Centre Ljubljana |
Responsible Party | University Medical Centre Ljubljana |
ClinicalTrials.gov Identifier | NCT01911468 |
First Received | July 21, 2013 |
Last Updated | July 26, 2013 |
Last verified | July 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | July 21, 2013 |
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Last Updated Date | July 26, 2013 |
Start Date | November 2011 |
Estimated Primary Completion Date | April 2013 |
Current Primary Outcome Measures | 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.] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin |
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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 |
Brief 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: metformin Other Names: Glucophage tabletsDrug: liraglutide Other Names: Victoza 6 mg/ml solution for injection in pre-filled penDrug: metformin and liraglutide Other Names: Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 36 |
Estimated Completion Date | April 2013 |
Estimated Primary Completion Date | October 2012 |
Eligibility 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 |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Slovenia |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01911468 |
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Other Study ID Numbers | 20120047-LIRA1 |
Has Data Monitoring Committee | No |
Information Provided By | University Medical Centre Ljubljana |
Study Sponsor | University Medical Centre Ljubljana |
Collaborators | Not Provided |
Investigators | Principal Investigator: Andrej Janez, MD PhD University Medical Centre Ljubljana |
Verification Date | July 2013 |
Locations[ + expand ][ + ]
University Medical Center Ljubljana | Ljubljana, Slovenia, 1000 |
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