USE OF NAFARELIN VERSUS PLACEBO AFTER REDUCTIVE LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS

Objective: To evaluate the efficacy of the GnRH agonist (GnRH-a) nafar elin compared with placebo administered for 6 months after reductive l aparoscopic surgery for symptomatic endometriosis. Design: Randomized, prospective, placebo-controlled, multicenter clinical trial. Setting: Thirteen clinics including private practice and university centers. P atient(s): One hundred nine women aged 18-47 with laparoscopically pro ven endometriosis and pelvic pain who had undergone reductive laparosc opic surgery for endometriosis. Intervention(s): Patients were randomi zed to receive either the GnRH-a nafarelin (200 mu g twice daily) or p lacebo for 6 months. Main Outcome Measure(s): Time to initiation of al ternative treatment (the length of time from beginning study medicatio n to receiving alternative therapy or to deeming that the study drug w as ineffective) and patient-reported and physician-assessed pelvic pai n scores. Result(s): The median time to initiation of alternative trea tment was >24 months in the nafarelin group versus 11.7 months in the placebo group. Fifteen (31%) of 49 nafarelin-treated patients required alternative therapy, compared with 25 (57%) of 44 placebo-treated pat ients. The patients' pelvic pain scores dropped significantly in the n afarelin and placebo groups after 6 months of treatment. Physician sum mary ratings showed significant improvement in the nafarelin group and no significant changes in the placebo group after 6 months of treatme nt. Conclusion(s): Compared with placebo, nafarelin administered after reductive laparoscopic surgery for endometriosis significantly delays the return of endometriosis symptoms requiring further treatment. (C) 1997 by American Society for Reproductive Medicine.