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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Poznan University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Yale University
Information provided by:
Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00396513
First received: November 3, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Poznan University of Medical Sciences

Additional 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
Study First Received: November 3, 2006
Last Updated: November 3, 2006
Health Authority: Poland: Ministry of Health

Keywords provided by Poznan University of Medical Sciences:
PCOS
Statin
Metformin
 Testosterone
Menstrual cycle
Lipids

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

ClinicalTrials.gov processed this record on June 17, 2013