Back to resultsSimvastatin Therapy in Women With Polycystic Ovary Syndrome.
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, statin, testosterone, lipids
Eligibility Criteria
Inclusion Criteria: PCO - ESHRE/ASRM criteria: oligomenorrhea (<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone >70ng/dl) 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 (transaminases) above 2 times of upper limit of normal Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics. Use of oral contraceptives and other steroid hormones 3 months prior to the study Contraindications to oral contraceptives
Sites / Locations
- Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Outcomes
Primary Outcome Measures
serum testosterone
Secondary Outcome Measures
serum lutropin
serum follitropin
serum lipids
serum DHEA-S
serum SHBG
serum insulin
Full Information
NCT ID
NCT00365638
First Posted
August 15, 2006
Last Updated
August 15, 2006
Sponsor
Poznan University of Medical Sciences
Collaborators
Yale University
1. Study Identification
Unique Protocol Identification Number
NCT00365638
Brief Title
Simvastatin Therapy in Women With Polycystic Ovary Syndrome.
Official Title
Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2004
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (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 determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) 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, testosterone, lipids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
simvastatin
Primary Outcome Measure Information:
Title
serum testosterone
Secondary Outcome Measure Information:
Title
serum lutropin
Title
serum follitropin
Title
serum lipids
Title
serum DHEA-S
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 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone >70ng/dl)
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 (transaminases) above 2 times of upper limit of normal
Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
Use of oral contraceptives and other steroid hormones 3 months prior to the study
Contraindications to oral contraceptives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leszek Pawelczyk, MD PhD
Organizational Affiliation
Poznan University of Medical Sciences
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 Obsterics
City
Poznan
ZIP/Postal Code
60-184
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
16580386
Citation
Duleba AJ, Banaszewska B, Spaczynski RZ, Pawelczyk L. Simvastatin improves biochemical parameters in women with polycystic ovary syndrome: results of a prospective, randomized trial. Fertil Steril. 2006 Apr;85(4):996-1001. doi: 10.1016/j.fertnstert.2005.09.030. Epub 2006 Mar 9.
Results Reference
result
PubMed Identifier
17105841
Citation
Banaszewska B, Pawelczyk L, Spaczynski RZ, Dziura J, Duleba AJ. Effects of simvastatin and oral contraceptive agent on polycystic ovary syndrome: prospective, randomized, crossover trial. J Clin Endocrinol Metab. 2007 Feb;92(2):456-61. doi: 10.1210/jc.2006-1988. Epub 2006 Nov 14.
Results Reference
derived
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Simvastatin Therapy in Women With Polycystic Ovary Syndrome.
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