Effects of 3 month therapy with danazol after laparoscopic surgery for stage III IV endometriosis: a randomized study

The effect of treatment with danazol was evaluated with respect to expectan t management after laparoscopic conservative surgery. All patients conserva tively operated at laparoscopy for stage III-IV endometriosis from July 199 4 to October 1996 were requested to enter the study. Patients who underwent surgery for recurrent endometriosis were excluded from the study, as well as patients who had taken hormonal therapies before laparoscopy. Informed c onsent was obtained from 77 women who were randomized after surgery to trea tment with danazol 600 mg daily for 3 months (n = 36) or to expectant manag ement (n = 41). All patients were regularly followed up every 6 months for evaluation of fertility, recurrence of pain symptoms and disease. During th e follow-up, six (55%) of the 11 infertile women allocated to danazol and e ight (50%) of the 16 given no treatment became pregnant (not significant). Moderate/severe pelvic pain recurred during follow-up in seven (23%) of the 31 women with pelvic pain allocated to the danazol group and nine (31%) of the 29 allocated to no treatment; the respective cumulative pain recurrenc e rates at 12 months were 26 and 34% (log rank test, not significant). Thre e women (8.3%) treated with danazol and six (15%) who received no treatment had disease recurrence as demonstrated by gynaecological examination and/o r pelvic ultrasonography (not significant). Our results do not demonstrate a significant advantage of 3 month danazol therapy after laparoscopic surge ry for stage III-IV endometriosis with respect to postoperative expectant m anagement.