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

November 3, 2006
November 3, 2006
September 2005
Not Provided
Serum testosterone
Same as current
No Changes Posted
  • regularity of menstrual cycle
  • serum lutropin
  • serum follitropin
  • serum lipids
  • serum DHEAS
  • serum SHBG
  • serum insulin
Same as current
Not Provided
Not Provided
 
Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: Simvastatin
  • Drug: Simvastatin and Metformin
  • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
Not Provided
Not Provided

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
Female
18 Years to 40 Years
No
Contact: Beata E Banaszewska, MD PhD +48 618419412 bbeata@gpsk.am.poznan.pl
Contact: Robert Z Spaczynski, MD PhD +48 618419412 rspaczynski@yahoo.com
Poland
 
NCT00396513
1142/05
Not Provided
Not Provided
Poznan University of Medical Sciences
Yale University
Principal Investigator: Leszek Pawelczyk, MD PhD Poznan University of Medical Scienses
Study Director: Antoni J Duleba, MD Yale University
Poznan University of Medical Sciences
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP