- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00034047
Endometriosis : Traditional Medicine vs Hormone Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Endometriosis is a significant public health problem affecting 10-15% of women of childbearing age, many of whom suffer persistent pelvic pain and infertility. Therapeutic options include surgery and hormone therapy that are often temporarily effective but produce unwanted side-effects. The present proposal, based on case series reports of the effectiveness of Traditional Chinese Medicine (TCM: acupuncture and Chinese herbs) for this condition, aims to evaluate whether TCM is as effective as hormone therapy for alleviating endometriosis-related chronic pain.
Women with laparoscopy-diagnosed endometriosis will be randomly assigned to either TCM or hormone therapy. Women assigned to TCM will be divided into four sub-groups on the basis of the diagnostic categories of endometriosis recognized by TCM. A pre-established acupuncture protocol and herbal formula specific for each sub-group will be followed. This aspect of the research design permits an important feature of the clinical practice of TCM (matching treatment to sub-group diagnosis) to be adopted in a clinical trial. Women assigned to hormone therapy will be treated with the gonadotropin releasing hormone agonist (GnRHa), nafarelin, chosen for this study on the basis of its clinical trial-established efficacy, ease of patient usage via intranasal spray and milder side-effect profile relative to other GnRHa's. Pelvic pain symptoms (patient-scored) and signs (physician-scored) will be assessed at baseline, after 12 weeks of treatment, and at 12- and 24-week post-treatment follow-up. Pelvic examination scores will be determined by a physician blinded to the treatment group assignments. Side effects, including those of pseudomenopause known to result from GnRHa therapy, will be recorded in both groups at 4-week intervals during the 12-week treatment, and at each follow-up time. A further objective is to make a preliminary assessment of whether diagnostic sub-groups of endometriosis recognized by TCM serve as predictors of differential response to hormone therapy. Data obtained from this study, on treatment effectiveness, side effect profiles, recurrence of symptoms, compliance with therapy and drop-out rates, will be used to design a large-scale clinical trial.
Study Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97201
- Oregon Health Sciences University, Women's Health Research Unit
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Portland, Oregon, United States, 97216
- Oregon College of Oriental Medicine Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pain assessments
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Collaborators and Investigators
Investigators
- Principal Investigator: Richard Hammerschlag, PhD, Oregon College of Oriental Medicine
- Principal Investigator: Kenneth Burry, MD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT000453-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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