NCT00034047

Brief Summary

This 36-week study will determine whether traditional Chinese medicine (acupuncture and Chinese herbs) is as effective as hormone therapy for alleviating endometriosis-related pelvic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2002

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2002

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

Enrollment Period

3.9 years

First QC Date

April 19, 2002

Last Update Submit

January 23, 2008

Conditions

EndometriosisPelvic Pain

Keywords

EndometriosisPelvic painAcupunctureChinese herbsHormone therapyNafarelin

Outcome Measures

Primary Outcomes (1)

  • Pain assessments

Interventions

AcupuncturePROCEDURE
Chinese ProductsDRUG
NafarelinDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with laparoscopy-confirmed endometriosis within the past 6 years
  • Experiencing chronic pelvic pain, dysmenorrhea (painful periods) and dyspareunia (painful intercourse), at least one of which is moderate to severe

You may not qualify if:

  • Use of traditional Chinese medicine for endometriosis. If previous treatment with hormone therapy, must have responded positively but not have been on hormone therapy within the past 6 months
  • Use of any form of hormone-based contraception during the 12-week treatment and 24-week follow-up periods
  • Diagnosed with any chronic condition other than endometriosis, or any other acute condition that causes pain
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oregon Health Sciences University, Women's Health Research Unit

Portland, Oregon, 97201, United States

Location

Oregon College of Oriental Medicine Clinic

Portland, Oregon, 97216, United States

Location

MeSH Terms

Conditions

EndometriosisPelvic Pain

Interventions

Acupuncture TherapyNafarelin

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Richard Hammerschlag, PhD

    Oregon College of Oriental Medicine

    PRINCIPAL INVESTIGATOR

  • Kenneth Burry, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 19, 2002

First Posted

April 22, 2002

Study Start

September 1, 2002

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

US(2)