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

Tracking Information

First Received Date ^ICMJE

November 3, 2006

Last Updated Date

November 3, 2006

Start Date ^ICMJE

September 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Serum testosterone

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

regularity of menstrual cycle
serum lutropin
serum follitropin
serum lipids
serum DHEAS
serum SHBG
serum insulin

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial

Brief Summary

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Polycystic Ovary Syndrome

Intervention ^ICMJE

Drug: Simvastatin
Drug: Simvastatin and Metformin
Drug: Metformin

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00396513

Other Study ID Numbers ^ICMJE

1142/05

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Poznan University of Medical Sciences

Collaborators ^ICMJE

Yale University

Investigators ^ICMJE

Principal Investigator:	Leszek Pawelczyk, MD PhD	Poznan University of Medical Scienses
Study Director:	Antoni J Duleba, MD	Yale University

Information Provided By

Poznan University of Medical Sciences

Verification Date

November 2006

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

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