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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Poznan University of Medical Sciences.
Recruitment status was:  Recruiting
Yale University
Information provided by:
Poznan University of Medical Sciences Identifier:
First received: November 3, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
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 Intervention
Polycystic Ovary Syndrome Drug: Simvastatin Drug: Simvastatin and Metformin Drug: Metformin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Poznan University of Medical Sciences:

Primary Outcome Measures:
  • Serum testosterone

Secondary Outcome Measures:
  • regularity of menstrual cycle
  • serum lutropin
  • serum follitropin
  • serum lipids
  • serum DHEAS
  • serum SHBG
  • serum insulin

Study Start Date: September 2005

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00396513

Contact: Beata E Banaszewska, MD PhD +48 618419412
Contact: Robert Z Spaczynski, MD PhD +48 618419412

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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00396513     History of Changes
Other Study ID Numbers: 1142/05
Study First Received: November 3, 2006
Last Updated: November 3, 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 processed this record on September 21, 2017