NCT01072097

Brief Summary

This is a placebo controlled trial investigating the effect of 6 months atorvastatin 20mg/day therapy on androgens, glucose metabolism and inflammatory markers in women with PCOS. We assume that during 6 months atorvastatin therapy a significant improvement in hyperandrogenism, glucose metabolism and inflammatory markers is observed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 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

September 1, 2006

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

September 7, 2011

Status Verified

September 1, 2011

Enrollment Period

4.3 years

First QC Date

February 18, 2010

Last Update Submit

September 6, 2011

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSAtorvastatinAndrogensGlucose metabolismInflammatory markers

Outcome Measures

Primary Outcomes (2)

  • Androgen secretion

    0, 3, 6 months

  • Glucose metabolism

    0, (3), 6 months

Secondary Outcomes (1)

  • Inflammatory markers

    0, 3, 6 months

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

6 months atorvastatin 20mg/day treatment

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

6 months placebo treatment

Drug: Placebo

Interventions

AtorvastatinDRUG

Atorvastatin 20mg/day for 6 months

Also known as: Lipitor 20mg, Pfizer
Atorvastatin
PlaceboDRUG

Placebo for 6 months

Placebo

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed for PCOS (Rotterdam criteria)
  • aged 30-50 years
  • safe non-hormonal contraception

You may not qualify if:

  • use of cholesterol lowering agents
  • use of antidepressants
  • use of cortisone medication (p.o.)
  • use of hormonal contraception
  • nursing
  • pregnancy
  • DM-T2
  • liver disease
  • menopause
  • kidney or liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology, University of Oulu

Oulu, 90014, Finland

Location

Related Publications (2)

  • 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

  • Puurunen J, Piltonen T, Puukka K, Ruokonen A, Savolainen MJ, Bloigu R, Morin-Papunen L, Tapanainen JS. Statin therapy worsens insulin sensitivity in women with polycystic ovary syndrome (PCOS): a prospective, randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2013 Dec;98(12):4798-807. doi: 10.1210/jc.2013-2674. Epub 2013 Oct 23.

    PMID: 24152688DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Terhi T. Piltonen, MD, PhD

    Dept Ob-Gyn, University of Oulu

    STUDY DIRECTOR

  • Johanna Puurunen, MD

    Dept Ob-Gyn, University of Oulu

    PRINCIPAL INVESTIGATOR

  • Juha S. Tapanainen, Professor

    Dept Ob-Gyn, Univeristy of Oulu

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

September 1, 2006

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

September 7, 2011

Record last verified: 2011-09

Locations

FI(1)