Back to resultsSimvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Simvastatin
Simvastatin and Metformin
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, Statin, Metformin, Testosterone, Menstrual cycle, Lipids
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
Sites / Locations
- Division of Infertility and Reproductive Endocrinology, Department of Gynecology and ObstetricsRecruiting
Outcomes
Primary Outcome Measures
Serum testosterone
Secondary Outcome Measures
regularity of menstrual cycle
serum lutropin
serum follitropin
serum lipids
serum DHEAS
serum SHBG
serum insulin
Full Information
NCT ID
NCT00396513
First Posted
November 3, 2006
Last Updated
November 3, 2006
Sponsor
Poznan University of Medical Sciences
Collaborators
Yale University
1. Study Identification
Unique Protocol Identification Number
NCT00396513
Brief Title
Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
Official Title
Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Poznan University of Medical Sciences
Collaborators
Yale University
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, Statin, Metformin, Testosterone, Menstrual cycle, Lipids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Type
Drug
Intervention Name(s)
Simvastatin and Metformin
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
Serum testosterone
Secondary Outcome Measure Information:
Title
regularity of menstrual cycle
Title
serum lutropin
Title
serum follitropin
Title
serum lipids
Title
serum DHEAS
Title
serum SHBG
Title
serum insulin
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beata E Banaszewska, MD PhD
Phone
+48 618419412
Email
bbeata@gpsk.am.poznan.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Z Spaczynski, MD PhD
Phone
+48 618419412
Email
rspaczynski@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leszek Pawelczyk, MD PhD
Organizational Affiliation
Poznan University of Medical Scienses
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoni J Duleba, MD
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics
City
Poznan
ZIP/Postal Code
60-184
Country
Poland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
21865358
Citation
Banaszewska B, Pawelczyk L, Spaczynski RZ, Duleba AJ. Effects of simvastatin and metformin on polycystic ovary syndrome after six months of treatment. J Clin Endocrinol Metab. 2011 Nov;96(11):3493-501. doi: 10.1210/jc.2011-0501. Epub 2011 Aug 24.
Results Reference
derived
PubMed Identifier
19890022
Citation
Banaszewska B, Pawelczyk L, Spaczynski RZ, Duleba AJ. Comparison of simvastatin and metformin in treatment of polycystic ovary syndrome: prospective randomized trial. J Clin Endocrinol Metab. 2009 Dec;94(12):4938-45. doi: 10.1210/jc.2009-1674. Epub 2009 Nov 4.
Results Reference
derived
Learn more about this trial
Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
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