Updating the clinical experience in endometriosis--the Brazilian perspective

Abstract

In an open-label, multicentre, randomized, parallel group study, 164 women with endometriosis were assigned to treatment. Out of these women, 81 received danazol (600 mg daily for 8 weeks, then 400 mg for 16 weeks) and 83 were given gestrinone (2.5 mg twice a week for 24 weeks). Five weeks before the start of treatment clinical evaluation and diagnostic laparoscopy were performed during the screening visit. Drug assignment and laboratory data assessment were carried out within 3 days of the estimated onset of the menstrual cycle at baseline visit. The response to treatment was assessed during visits at weeks 2, 4, 8, 12, 16, 20 and 24; at the last visit a second laparoscopy was performed. Therapeutic efficacy was evaluated by analysis of the laparoscopic scores assessed according to the revised American Fertility Society classification. Symptomatic response was measured by clinical scores and laboratory data. In one centre, bone mineral density was also recorded. One patient in the danazol group discontinued treatment due to a cutaneous rash as a probable adverse reaction at the beginning of the study. The therapeutic efficacy of danazol and gestrinone did not differ significantly when the revised American Fertility Society scores were compared. The symptomatic response also showed no statistical difference when clinical examination scores were analysed. There was no significant difference between the drugs in laboratory data, including bone mineral density, with respect to adverse events. Analysis of clinical scores showed that danazol was superior to gestrinone with respect to acne and irregular bleeding. Based on these data, we conclude that both danazol and gestrinone are reliable in the treatment of endometriosis and offer similar results.