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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02483299 |
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Date of registration:
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24/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome
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Scientific title:
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Date of first enrolment:
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January 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02483299 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Slovenia
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Obesity
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PCOS
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Intervention(s)
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Drug: Metformin
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Drug: Glucophage tablets and Victoza
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Primary Outcome(s)
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Change in body weight
[Time Frame: up to 12 weeks of clinical trial]
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The number of good responders to combined treatment regarding body weight
[Time Frame: up to 12 weeks of clinical trial]
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Secondary Outcome(s)
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Change in body mass index (BMI).
[Time Frame: up to 12 weeks of clinical trial]
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Change in waist circumference
[Time Frame: up to 12 weeks of clinical trial]
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Secondary ID(s)
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LIRA COMBI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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