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NCT00396513 Clinical Trial

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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00396513
Other study ID # 1142/05
Secondary ID
Status Recruiting
Phase N/A
First received November 3, 2006
Last updated November 3, 2006
Start date September 2005

Study information
Verified date November 2006
Source Poznan University of Medical Sciences
Contact Beata E Banaszewska, MD PhD
Phone +48 618419412
Email bbeata@gpsk.am.poznan.pl
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Simvastatin

• Simvastatin and Metformin

• Metformin

Locations
Country Name City State
Poland Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics Poznan

Sponsors (2)
Lead Sponsor Collaborator
Poznan University of Medical Sciences Yale University

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum testosterone
Secondary regularity of menstrual cycle
Secondary serum lutropin
Secondary serum follitropin
Secondary serum lipids
Secondary serum DHEAS
Secondary serum SHBG
Secondary serum insulin
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Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
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