Acupuncture for Polycystic Ovarian Syndrome | NCT00602940

Studies
Acupuncture for Polycystic Ovarian Syndrome

NCT00602940

Sponsor

University of Virginia

Status

Unknown status

Last Update Posted

May 21, 2010Estimated

Enrollment

78Estimated

Phase

Not Applicable

Conditions

Polycystic Ovary Syndrome

Interventions

Acupuncture
Sham Acupuncture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NIH R21 AT002520

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jan 15, 2008

First Submission Date that Met QC Criteria

Jan 26, 2008

First Posted Date

Jan 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2010

Last Update Posted Date

May 21, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Active acupuncture treatment	Procedure: Acupuncture
2	Sham Comparator	Sham acupuncture treatment	Procedure: Sham Acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure	12 treatments over 8 weeks	1
Sham Acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ovulation in 2 out of 5 months of study participation		monthly

Secondary Outcomes

Measure	Description	Time Frame
changes in follicle stimulating hormone and luteinizing hormone		baseline vs. 2 months vs. 5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lisa M Pastore, PhD	UVA OB/GYN Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21911106	Derived	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.

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics