Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00365638
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : August 17, 2006
Yale University
Information provided by:
Poznan University of Medical Sciences

Brief Summary:
The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: simvastatin Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.
Study Start Date : April 2004
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Primary Outcome Measures :
  1. serum testosterone

Secondary Outcome Measures :
  1. serum lutropin
  2. serum follitropin
  3. serum lipids
  4. serum DHEA-S
  5. serum SHBG
  6. serum insulin

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone >70ng/dl)
  • 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 (transaminases) above 2 times of upper limit of normal
  • Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
  • Use of oral contraceptives and other steroid hormones 3 months prior to the study
  • Contraindications to oral contraceptives

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 identifier (NCT number): NCT00365638

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00365638     History of Changes
Other Study ID Numbers: 636/04
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: August 17, 2006
Last Verified: September 2004

Keywords provided by Poznan University of Medical Sciences:

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