NCT00365638

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
Last Updated

August 17, 2006

Status Verified

September 1, 2004

First QC Date

August 15, 2006

Last Update Submit

August 15, 2006

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSstatintestosteronelipids

Outcome Measures

Primary Outcomes (1)

  • serum testosterone

Secondary Outcomes (6)

  • serum lutropin

  • serum follitropin

  • serum lipids

  • serum DHEA-S

  • serum SHBG

  • +1 more secondary outcomes

Interventions

simvastatinDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Poznan, 60-184, Poland

Location

Related Publications (3)

  • 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.

    PMID: 16580386RESULT

  • Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3.

    PMID: 37462232DERIVED

  • 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.

    PMID: 17105841DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Leszek Pawelczyk, MD PhD

    Poznan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Antoni J Duleba, MD

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

April 1, 2004

Study Completion

February 1, 2005

Last Updated

August 17, 2006

Record last verified: 2004-09

Locations

PL(1)