Nafarelin for Endometriosis - a Large-scale, Danazol-controlled Trial of Efficacy and Safety, With 1-year Follow-up

Objective: To compare the efficacy and safety of nafarelin and danazol for endometriosis.\nDesign: Randomized, double-blind, double-dummy.\nSetting: Multiple European institutions.\nPatients: In total, 307 patients with laparoscopically diagnosed endometriosis received nafarelin (n = 206) or danazol (n = 101); 263 (171 nafarelin, 92 danazol) were analyzed for efficacy.\nInterventions: Intranasal nafarelin 200-mu-g two times a day or oral danazol 200 mg three times a day were administered for 6 months.\nMain Outcome Measures: Efficacy assessments were based on preadmission and end-of-treatment laparoscopic scores and subjective symptom scores at admission, end of treatment, 1, 3, 6, and 12 months after treatment. Safety was evaluated by adverse events and clinical laboratory tests.\nResults: In each group, endometriosis growth and symptoms significantly improved during treatment (P < 0.001). After treatment, symptoms returned in each group, but severity was less than at admission at all time points (P less-than-or-equal-to 0.016). Mean body weight increased in the danazol-treated group (P < 0.001), serum glutamic oxaloacetic transaminase increased in both groups (P < 0.001 for both) but significantly more in danazol users (P < 0.002), and more nafarelin recipients had hot flushes (P < 0.001).\nConclusions: Nafarelin and danazol were equally effective in reducing endometriosis growth and symptoms during treatment and in preventing the return of symptoms during 12-month followup.