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Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.

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ClinicalTrials.gov Identifier: NCT00396513
Recruitment Status : Unknown
Verified November 2006 by Poznan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 7, 2006
Last Update Posted : November 7, 2006
Yale University
Information provided by:
Poznan University of Medical Sciences

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).

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Drug: Simvastatin Drug: Simvastatin and Metformin Drug: Metformin

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial
Study Start Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Serum testosterone

Secondary Outcome Measures :
  1. regularity of menstrual cycle
  2. serum lutropin
  3. serum follitropin
  4. serum lipids
  5. serum DHEAS
  6. serum SHBG
  7. serum insulin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396513

Contact: Beata E Banaszewska, MD PhD +48 618419412 bbeata@gpsk.am.poznan.pl
Contact: Robert Z Spaczynski, MD PhD +48 618419412 rspaczynski@yahoo.com

Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics Recruiting
Poznan, Poland, 60-184
Sponsors and Collaborators
Poznan University of Medical Sciences
Yale University
Principal Investigator: Leszek Pawelczyk, MD PhD Poznan University of Medical Scienses
Study Director: Antoni J Duleba, MD Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00396513     History of Changes
Other Study ID Numbers: 1142/05
First Posted: November 7, 2006    Key Record Dates
Last Update Posted: November 7, 2006
Last Verified: November 2006

Keywords provided by Poznan University of Medical Sciences:
Menstrual cycle

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors