Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 3, 2006
CompletedFirst Posted
Study publicly available on registry
November 7, 2006
CompletedNovember 7, 2006
November 1, 2006
November 3, 2006
November 3, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum testosterone
Secondary Outcomes (7)
regularity of menstrual cycle
serum lutropin
serum follitropin
serum lipids
serum DHEAS
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Poznan University of Medical Scienceslead
- Yale Universitycollaborator
Study Sites (1)
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics
Poznan, 60-184, Poland
Related Publications (3)
Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3.
PMID: 37462232DERIVEDBanaszewska B, Pawelczyk L, Spaczynski RZ, Duleba AJ. Effects of simvastatin and metformin on polycystic ovary syndrome after six months of treatment. J Clin Endocrinol Metab. 2011 Nov;96(11):3493-501. doi: 10.1210/jc.2011-0501. Epub 2011 Aug 24.
PMID: 21865358DERIVEDBanaszewska B, Pawelczyk L, Spaczynski RZ, Duleba AJ. Comparison of simvastatin and metformin in treatment of polycystic ovary syndrome: prospective randomized trial. J Clin Endocrinol Metab. 2009 Dec;94(12):4938-45. doi: 10.1210/jc.2009-1674. Epub 2009 Nov 4.
PMID: 19890022DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leszek Pawelczyk, MD PhD
Poznan University of Medical Scienses
- STUDY DIRECTOR
Antoni J Duleba, MD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 3, 2006
First Posted
November 7, 2006
Study Start
September 1, 2005
Last Updated
November 7, 2006
Record last verified: 2006-11