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OpenTrials
Completed

NCT Number: NCT00365638

Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

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).

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics

Poznan, 60-184, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

Primary outcomes

  1. serum testosterone

Secondary outcomes

  1. serum lutropin

  2. serum follitropin

  3. serum lipids

  4. serum DHEA-S

  5. serum SHBG

  6. serum insulin

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Collaborators

  • Yale University

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Aug 17, 2006
Registry last updated
Aug 17, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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