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

Overview[ - collapse ][ - ]

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).
ConditionPolycystic Ovary Syndrome
InterventionDrug: Simvastatin
Drug: Simvastatin and Metformin
Drug: Metformin
PhaseN/A
SponsorPoznan University of Medical Sciences
Responsible PartyPoznan University of Medical Sciences
ClinicalTrials.gov IdentifierNCT00396513
First ReceivedNovember 3, 2006
Last UpdatedNovember 3, 2006
Last verifiedNovember 2006

Tracking Information[ + expand ][ + ]

First Received DateNovember 3, 2006
Last Updated DateNovember 3, 2006
Start DateSeptember 2005
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresSerum testosterone
Current Secondary Outcome Measures
  • regularity of menstrual cycle
  • serum lutropin
  • serum follitropin
  • serum lipids
  • serum DHEAS
  • serum SHBG
  • serum insulin

Descriptive Information[ + expand ][ + ]

Brief TitleSimvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
Official TitleEffect 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 DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionPolycystic Ovary Syndrome
InterventionDrug: Simvastatin
Drug: Simvastatin and Metformin
Drug: Metformin
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated EnrollmentNot Provided
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility 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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Beata E Banaszewska, MD PhD
+48 618419412
bbeata@gpsk.am.poznan.pl
Location CountriesPoland

Administrative Information[ + expand ][ + ]

NCT Number NCT00396513
Other Study ID Numbers1142/05
Has Data Monitoring CommitteeNot Provided
Information Provided ByPoznan University of Medical Sciences
Study SponsorPoznan University of Medical Sciences
CollaboratorsYale University
Investigators Principal Investigator: Leszek Pawelczyk, MD PhD Poznan University of Medical SciensesStudy Director: Antoni J Duleba, MD Yale University
Verification DateNovember 2006

Locations[ + expand ][ + ]

Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics
Poznan, Poland, 60-184
Recruiting