Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS
Overview[ - collapse ][ - ]
| Purpose | Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders. The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk. |
|---|---|
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin Drug: Ethynyl-estradiol plus cyproterone acetate |
| Phase | Phase 4 |
| Sponsor | Hospital Universitario Ramon y Cajal |
| Responsible Party | Hospital Universitario Ramon y Cajal |
| ClinicalTrials.gov Identifier | NCT00428311 |
| First Received | January 29, 2007 |
| Last Updated | January 30, 2007 |
| Last verified | January 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 29, 2007 |
|---|---|
| Last Updated Date | January 30, 2007 |
| Start Date | April 2004 |
| Estimated Primary Completion Date | October 2006 |
| Current Primary Outcome Measures |
|
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS |
|---|---|
| Official Title | The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives |
| Brief Summary | Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders. The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin Drug: Ethynyl-estradiol plus cyproterone acetate |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | October 2006 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Women of fertile age presenting with PCOS - Non-hyperandrogenic women of fertile age (these women will not receive the interventions and will serve only to obtain normative data for some variables) Exclusion Criteria: - Severe disease not related to the condition under study - Pregnancy - Medical or surgical treatment of PCOS during the previous 3 months - Contraindication for the use of oral contraceptives or metformin - Inability to understand the proposal of the study precluding effective informed consent - Minors who are not accompanied by their legal representative |
| Gender | Female |
| Ages | 12 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Spain |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00428311 |
|---|---|
| Other Study ID Numbers | ENDOPCOS 01/2003 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Hospital Universitario Ramon y Cajal |
| Study Sponsor | Hospital Universitario Ramon y Cajal |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Héctor F Escobar-Morreale, MD, PhD Hospital Universitario Ramón y Cajal |
| Verification Date | January 2007 |
Locations[ + expand ][ + ]
| Department of Endocrinology, Hospital Ramón y Cajal | Madrid, Spain, E-28034 |
|---|