Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

Sponsor
Poznan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00365638
Collaborator
Yale University (Other)
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Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
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 :
Apr 1, 2004
Study Completion Date :
Feb 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00365638
Other Study ID Numbers:
  • 636/04
First Posted:
Aug 17, 2006
Last Update Posted:
Aug 17, 2006
Last Verified:
Sep 1, 2004
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2006