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Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

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ClinicalTrials.gov Identifier: NCT00365638
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : August 17, 2006
Sponsor:
Collaborator:
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
U.S. FDA Resources




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


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

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 ClinicalTrials.gov identifier (NCT number): NCT00365638


Locations
Poland
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
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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:
PCOS
statin
testosterone
lipids

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