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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00602940
Other study ID # 12045
Secondary ID NIH R21 AT002520
Status Active, not recruiting
Phase N/A
First received January 15, 2008
Last updated May 20, 2010
Start date January 2006
Est. completion date December 2010

Study information

Verified date May 2010
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 78
Est. completion date December 2010
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 43 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- pregnant

- use of hormonal drugs 30/60 days before the study entry

- acupuncture for ovulatory disorders 30 days prior to study entry

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Acupuncture
12 treatments over 8 weeks
Sham Acupuncture
12 treatments over 8 weeks

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ovulation in 2 out of 5 months of study participation monthly No
Secondary changes in follicle stimulating hormone and luteinizing hormone baseline vs. 2 months vs. 5 months No
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