| Trial ID: | L0532 |
| Source ID: | EUCTR2009-015927-94-GB
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| Associated Drug: |
Metformin
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| Title: |
Are early and late cardiovascular risk markers in women with Polycystic Ovary Syndrome increased with concomitant Nonalcoholic Steatohepatitis and can this be modified with Liraglutide?
|
| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
Has Results
|
| Results: |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-015927-94/results
|
| Conditions: |
Polycystic Ovary Syndrome
Non-alcoholic Steatohepatitis
<br>
MedDRA version: 12.0
Level: LLT
Classification code 10065161
Term: Polycystic ovarian syndrome
<br>
|
| Interventions: |
<br> Trade Name: Victoza<br> Pharmaceutical Form: Solution for injection<br> INN or Proposed INN: LIRAGLUTIDE<br> CAS Number: 204656-20-2<br> Concentration unit: mg/ml milligram(s)
|
| Outcome Measures: |
<br> Main Objective: 1. To show that intervention with Liraglutide significantly improves insulin resistance (an adverse cardiovascular risk marker)<br> 2. To determine if Metformin therapy maintains insulin resistance and markers of PCOS after treatment with Liraglutide.<br> ;<br> Secondary Objective: 1. To show that intervention with Liraglutide significantly improves endothelial function (Early manifestation of cardiovascular disease) in subjects with Polycystic Ovary Syndrome (PCOS) and Nonalcoholic Steatohepatitis (NASH)<br> 2. To determine if Liraglutide therapy significantly improves fibrin clot structure and function (Late manifestation of cardiovascular disease) in subjects with PCOS and NASH.<br> 3. To determine if Liraglutide is effective in reducing steatohepatitis by Fibroscan and reduces the markers of liver fibrosis<br> ;Primary end point(s): This study will demonstrate if the combination of PCO and NASH are additive for cardiovascular risk and whether Liraglutide may modify this. The study will demonstrate if Metformin maintains the modification of the cardiovascular risk after 6 months treatment of Liragltuide.nan
|
| Sponsor/Collaborators: |
Hull and East Yorkshire NHS Trust
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| Gender: |
Female
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| Age: |
nannan
|
| Phases: |
Phase 4
|
| Enrollment: |
36
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
<br> Controlled: yes<br> Randomised: no<br> Open: yes<br> Single blind: no<br> Double blind: no<br> Parallel group: no<br> Cross over: no<br>
|
| Start Date: |
17/03/2010
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| Completion Date: |
04/01/2013
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| Results First Posted: |
16/05/2019
|
| Last Update Posted: |
25 November 2019
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| Locations: |
United Kingdom
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015927-94
|
