Acupuncture for Polycystic Ovarian Syndrome

NCT ID: NCT00602940

Last Updated: 2010-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Active acupuncture treatment

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

12 treatments over 8 weeks

2

Sham acupuncture treatment

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type PROCEDURE

12 treatments over 8 weeks

Interventions

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Acupuncture

12 treatments over 8 weeks

Intervention Type PROCEDURE

Sham Acupuncture

12 treatments over 8 weeks

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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UVA

Principal Investigators

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Lisa M Pastore, PhD

Role: PRINCIPAL_INVESTIGATOR

UVA OB/GYN Department

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21911106 (View on PubMed)

Other Identifiers

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NIH R21 AT002520

Identifier Type: -

Identifier Source: secondary_id

12045

Identifier Type: -

Identifier Source: org_study_id

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