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


N/A
18 Years
40 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover 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 Sciences

Authority:

Poland: Ministry of Health

Study ID:

636/04

NCT ID:

NCT00365638

Start Date:

April 2004

Completion Date:

February 2005

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • statin
  • testosterone
  • lipids
  • Polycystic Ovary Syndrome

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