POSTSURGICAL MEDICAL-TREATMENT OF ADVANCED ENDOMETRIOSIS - RESULTS OFA RANDOMIZED CLINICAL-TRIAL

OBJECTIVE: Our purpose was to investigate the efficacy of postsurgical treatment with nafarelin in women with advanced endometriosis. STUDY DESIGN: Eligible for trial were women less than or equal to 38 years o ld with unexplained infertility with or without chronic pelvic pain an d stage III or IV endometriosis according to the American Fertility So ciety, revised, classification who underwent laparotomy as first surgi cal treatment for debulking or radical surgery of endometriotic lesion s. Patients were assigned according to a randomization list to nasal n afarelin, 400 mu g/day (36 subjects) or placebo nasal spray (39 subjec ts) for 3 months. Pelvic pain was assessed before first surgery and at the 12-month follow-up visit in women with pelvic pain by means of a multidimensional score system and a 10-point linear pain scale. RESULT S: No marked differences in pain scores emerged among women allocated to different treatments. The mean reduction of the multidimensional sc ore was 3.6 and 4.0, respectively, in women allocated to nafarelin and placebo and of the 10-point linear scale scores was 7.0 and 6.9. Thes e differences were not statistically significant. Within 1 year from r andomization, of the 36 women allocated to nafarelin and the 39 alloca ted to placebo, seven (19%) and seven (18%), respectively, became preg nant. CONCLUSION: This study suggests that medical treatment with nafa relin does not markedly improve pelvic pain and short-term reproductiv e prognosis in women with stages III and IV endometriosis.