Status:
COMPLETED
Medical Treatment of Endometriosis-Associated Pelvic Pain
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Endometriosis
Pelvic Pain
Eligibility:
FEMALE
18-52 years
Phase:
PHASE3
Brief Summary
The Specific Aim of this project is to compare the efficacy and cost-effectiveness of continuous oral contraceptives versus leuprolide/norethindrone in the treatment of endometriosis-associated chroni...
Detailed Description
* Background-Laparoscopic surgical treatment for endometriosis is typically associated with a decrease of pain on a short-term basis, but 50% of patients have pain 12 months after surgery. Often this ...
Eligibility Criteria
Inclusion
- Age greater than 18 and pre-menopausal.
- Pelvic pain of at least 3 months duration.
- Diagnosis of endometriosis by laparoscopy or laparotomy within three years of entry. The diagnosis of endometriosis will require either histology consistent with endometriosis or operative records indicating visual evidence of lesions consistent with endometriosis.
- Moderate to severe pelvic pain preoperatively attributable to endometriosis (average Numerical Rating Scale of 5 or more for three or more months).
- Willingness to comply with visit schedule and protocol.
Exclusion
- Use of oral contraceptives within one month of the surgery.
- Dose of Lupron within three months if given monthly or within five months if given 3-month injection.
- Any disorder that represents a contraindication to the use of oral contraceptives (e.g. insulin-dependent diabetes mellitus, history of thrombophlebitis, hypertension, history of cardiovascular disease, smoker at 35 or more years of age) or GnRH analogs (e.g., history of osteopenia).
- History of hysterectomy and bilateral salpingoophorectomy.
- Positive pregnancy test at first postoperative (i.e, intake visit).
- Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00229996
Start Date
July 1 2004
Last Update
January 24 2014
Active Locations (1)
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1
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02215