Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365638
• Other study ID #: 636/04
• Status: Completed
• Phase: N/A
• First received: August 15, 2006
• Last updated: August 15, 2006
• Start date: April 2004
• Est. completion date: February 2005

Study information

• Verified date: September 2004
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• simvastatin

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences	Yale University

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. Epub 2006 Mar 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum testosterone
Secondary	serum lutropin
Secondary	serum follitropin
Secondary	serum lipids
Secondary	serum DHEA-S
Secondary	serum SHBG
Secondary	serum insulin