Nafarelin for endometriosis: a large-scale, danazol-controlled trial of efficacy and safety, with 1-year follow-up. The Nafarelin European Endometriosis Trial Group (NEET).
OBJECTIVE
To compare the efficacy and safety of nafarelin and danazol for endometriosis.


METHODS
Randomized, double-blind, double-dummy.


METHODS
Multiple European institutions.


METHODS
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.


METHODS
Intranasal nafarelin 200 micrograms two times a day or oral danazol 200 mg three times a day were administered for 6 months.


METHODS
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.


RESULTS
In each group, endometriosis growth and symptoms significantly improved during treatment (P less than 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 less than 0.001), serum glutamic oxaloacetic transaminase increased in both groups (P less than 0.001 for both) but significantly more in danazol users (P less than 0.002), and more nafarelin recipients had hot flushes (P less than 0.001).


CONCLUSIONS
Nafarelin and danazol were equally effective in reducing endometriosis growth and symptoms during treatment and in preventing the return of symptoms during 12-month follow-up.
D000281:Administration, Intranasal; D000284:Administration, Oral; D000328:Adult; D001219:Aspartate Aminotransferases / Q000097:blood; D001835:Body Weight; D003613:Danazol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004715:Endometriosis / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D017274:Nafarelin; D016896:Treatment Outcome
D017274:Nafarelin; D007987:Gonadotropin-Releasing Hormone; D001219:Aspartate Aminotransferases; D003613:Danazol