Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS). |
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Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Simvastatin Drug: Simvastatin and Metformin Drug: Metformin |
Phase | N/A |
Sponsor | Poznan University of Medical Sciences |
Responsible Party | Poznan University of Medical Sciences |
ClinicalTrials.gov Identifier | NCT00396513 |
First Received | November 3, 2006 |
Last Updated | November 3, 2006 |
Last verified | November 2006 |
Tracking Information[ + expand ][ + ]
First Received Date | November 3, 2006 |
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Last Updated Date | November 3, 2006 |
Start Date | September 2005 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Serum testosterone |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial. |
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Official Title | Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial |
Brief Summary | The purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Simvastatin Drug: Simvastatin and Metformin Drug: Metformin |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | Not Provided |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | Inclusion Criteria: - PCO - ESHRE/ASRM criteria:oligomenorrhea (<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone > 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy Exclusion Criteria: - elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Beata E Banaszewska, MD PhD +48 618419412 bbeata@gpsk.am.poznan.pl |
Location Countries | Poland |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00396513 |
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Other Study ID Numbers | 1142/05 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Poznan University of Medical Sciences |
Study Sponsor | Poznan University of Medical Sciences |
Collaborators | Yale University |
Investigators | Principal Investigator: Leszek Pawelczyk, MD PhD Poznan University of Medical SciensesStudy Director: Antoni J Duleba, MD Yale University |
Verification Date | November 2006 |
Locations[ + expand ][ + ]
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics | Poznan, Poland, 60-184 Recruiting |
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