Medical Treatment of Endometriosis-Associated Pelvic Pain

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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 chronic pelvic pain. This comparison will be based on a randomized, double-blind, trial of women with chronic pelvic pain who have been diagnosed with endometriosis at the time of surgery within the last 3 years. We hypothesize that, over a 12-month period of postoperative treatment, the efficacy of oral contraceptives is no worse than leuprolide/norethindrone, and that treatment with oral contraceptives is more cost-effective.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Contraceptive Agents; Contraceptives, Oral; Leuprolide; Norethindrone; Norethindrone Acetate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.