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Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Poznan University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00396513
First Posted: November 7, 2006
Last Update Posted: November 7, 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 compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS).

Condition Intervention
Polycystic Ovary Syndrome Drug: Simvastatin Drug: Simvastatin and Metformin Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised 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:
  • regularity of menstrual cycle
  • serum lutropin
  • serum follitropin
  • serum lipids
  • serum DHEAS
  • serum SHBG
  • serum insulin

Study Start Date: September 2005
  Eligibility

Information from the National Library of Medicine

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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 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone > 70 ng/ml) 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 (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study
  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): NCT00396513


Contacts
Contact: Beata E Banaszewska, MD PhD +48 618419412 bbeata@gpsk.am.poznan.pl
Contact: Robert Z Spaczynski, MD PhD +48 618419412 rspaczynski@yahoo.com

Locations
Poland
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics Recruiting
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 Scienses
Study Director: Antoni J Duleba, MD Yale University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00396513     History of Changes
Other Study ID Numbers: 1142/05
First Submitted: November 3, 2006
First Posted: November 7, 2006
Last Update Posted: November 7, 2006
Last Verified: November 2006

Keywords provided by Poznan University of Medical Sciences:
PCOS
Statin
Metformin
Testosterone
Menstrual cycle
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
Metformin
Simvastatin
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors