Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial. - Full Text View

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

This study is currently recruiting participants.
Verified by Poznan University of Medical Sciences, November 2006

Sponsors and Collaborators:	Poznan University of Medical Sciences Yale University
Information provided by:	Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00396513

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

MedlinePlus related topics:

Menstruation

Drug Information available for:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Metformin Metformin hydrochloride Simvastatin Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

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

Study ID Numbers:	1142/05
First Received:	November 3, 2006
Last Updated:	November 3, 2006
ClinicalTrials.gov Identifier:	NCT00396513
Health Authority:	Poland: Ministry of Health

Keywords provided by Poznan University of Medical Sciences:

PCOS

Statin

Metformin

Testosterone

Menstrual cycle

Lipids

Study placed in the following topic categories:

Gonadal Disorders

Simvastatin

Metformin

Endocrine System Diseases

Ovarian Diseases

Methyltestosterone

Cysts

Testosterone 17 beta-cypionate

Genital Diseases, Female

Testosterone

Polycystic Ovary Syndrome

Endocrinopathy

Ovarian Cysts

Additional relevant MeSH terms:

Antimetabolites

Disease

Molecular Mechanisms of Pharmacological Action

Antilipemic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

Adnexal Diseases

Neoplasms

Pathologic Processes

Hypoglycemic Agents

Syndrome

Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2008