UPDATING THE CLINICAL-EXPERIENCE IN ENDOMETRIOSIS - THE BRAZILIAN PERSPECTIVE

In an open-label, multicentre, randomized, parallel group study, 164 w omen with endometriosis were assigned to treatment. Out of these women , 81 received danazol (600 mg daily for 8 weeks, then 400 mg for 16 we eks) and 83 were given gestrinone (2.5 mg twice a week for 24 weeks). Five weeks before the start of treatment clinical evaluation and diagn ostic laparoscopy were performed during the screening visit. Drug assi gnment and laboratory data assessment were carried out within 3 days o f the estimated onset of the menstrual cycle at baseline visit. The re sponse to treatment was assessed during visits at weeks 2, 4, 8, 12, 1 6, 20 and 24; at the last visit a second laparoscopy was performed. Th erapeutic efficacy was evaluated by analysis of the laparoscopic score s assessed according to the revised American Fertility Society classif ication. Symptomatic response was measured by clinical scores and labo ratory data. In one centre, bone mineral density was also recorded. On e patient in the danazol group discontinued treatment due to a cutaneo us rash as a probable adverse reaction at the beginning of the study. The therapeutic efficacy of danazol and gestrinone did not differ sign ificantly when the revised American Fertility Society scores were comp ared. The symptomatic response also showed no statistical difference w hen clinical examination scores were analysed. There was no significan t difference between the drugs in laboratory data, including bone mine ral density, with respect to adverse events. Analysis of clinical scor es showed that danazol was superior to gestrinone with respect to acne and irregular bleeding. Based on these data, we conclude that both da nazol and gestrinone are reliable in the treatment of endometriosis an d offer similar results.