NCT00602940

Brief Summary

This is a randomized control trial of acupuncture for women with polycystic ovary syndrome. The study is triple-blinded.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 21, 2010

Status Verified

May 1, 2010

Enrollment Period

3.9 years

First QC Date

January 15, 2008

Last Update Submit

May 20, 2010

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSovulationhormoneswomen

Outcome Measures

Primary Outcomes (1)

  • ovulation in 2 out of 5 months of study participation

    monthly

Secondary Outcomes (1)

  • changes in follicle stimulating hormone and luteinizing hormone

    baseline vs. 2 months vs. 5 months

Study Arms (2)

1

EXPERIMENTAL

Active acupuncture treatment

Procedure: Acupuncture

2

SHAM COMPARATOR

Sham acupuncture treatment

Procedure: Sham Acupuncture

Interventions

AcupuncturePROCEDURE

12 treatments over 8 weeks

1
Sham AcupuncturePROCEDURE

12 treatments over 8 weeks

2

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ages 18-43
  • confirmation of PCOS through the study
  • signed informed consent
  • able to receive study treatment at Virginia study sites
  • agree not to use hormonal medications for the 5 months of the study

You may not qualify if:

  • pregnant
  • use of hormonal drugs 30/60 days before the study entry
  • acupuncture for ovulatory disorders 30 days prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Pastore LM, Patrie JT, Morris WL, Dalal P, Bray MJ. Depression symptoms and body dissatisfaction association among polycystic ovary syndrome women. J Psychosom Res. 2011 Oct;71(4):270-6. doi: 10.1016/j.jpsychores.2011.02.005. Epub 2011 Mar 23.

    PMID: 21911106DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Lisa M Pastore, PhD

    UVA OB/GYN Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 28, 2008

Study Start

January 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

May 21, 2010

Record last verified: 2010-05

Locations

US(1)