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


N/A
18 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Serum testosterone

Principal Investigator

Leszek Pawelczyk, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Poznan University of Medical Scienses

Authority:

Poland: Ministry of Health

Study ID:

1142/05

NCT ID:

NCT00396513

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Statin
  • Metformin
  • Testosterone
  • Menstrual cycle
  • Lipids
  • Polycystic Ovary Syndrome

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