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Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by:
Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00365638
First received: August 15, 2006
Last updated: NA
Last verified: September 2004
History: No changes posted
  Purpose

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 Intervention
Polycystic Ovary Syndrome
 Drug: simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:

Drug Information available for: Simvastatin
U.S. FDA Resources

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

Primary Outcome Measures:
  • serum testosterone

Secondary Outcome Measures:
  • serum lutropin
  • serum follitropin
  • serum lipids
  • serum DHEA-S
  • serum SHBG
  • serum insulin

Study Start Date: April 2004
Estimated Study Completion Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Additional 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
Study First Received: August 15, 2006
Last Updated: August 15, 2006
Health Authority: Poland: Ministry of Health

Keywords provided by Poznan University of Medical Sciences:
PCOS
statin
testosterone
lipids

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

ClinicalTrials.gov processed this record on May 19, 2013