We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00365638
First Posted: August 17, 2006
Last Update Posted: August 17, 2006
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.
Collaborator:
Yale University
Information provided by:
Poznan University of Medical Sciences
  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
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.

Resource links provided by NLM:


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

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
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
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
  More Information

Publications:
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 Submitted: August 15, 2006
First Posted: August 17, 2006
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