Detailed analysis of a randomized, multicenter, comparative trial of dienogest versus leuprolide acetate in endometriosis

• Published in: International journal of gynecology and obstetrics 2012-06, Vol.117 (3), p.228-233
• Main Authors: Strowitzki, Thomas, Marr, Joachim, Gerlinger, Christoph, Faustmann, Thomas, Seitz, Christian
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antineoplastic Agents, Hormonal - therapeutic use; Biological and medical sciences; Dienogest; Dysmenorrhea - drug therapy; Dysmenorrhea - etiology; Endometriosis; Endometriosis - blood; Endometriosis - complications; Endometriosis - drug therapy; Estrogens - blood; Female; Female genital diseases; Gonadotropin-releasing hormone analog; Gynecology. Andrology. Obstetrics; Humans; Leuprolide - adverse effects; Leuprolide - therapeutic use; Medical sciences; Middle Aged; Nandrolone - adverse effects; Nandrolone - analogs & derivatives; Nandrolone - therapeutic use; Non tumoral diseases; Obstetrics and Gynecology; Pain relief; Pelvic Pain - drug therapy; Pelvic Pain - etiology; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Young Adult
• ISSN: 0020-7292; 1879-3479
• DOI: 10.1016/j.ijgo.2012.01.009

Abstract Objective To analyze the secondary efficacy and safety outcomes from a recent trial comparing dienogest (DNG) with leuprolide acetate (LA) in women with endometriosis. Methods A 24-week, open-label, randomized, multicenter study of DNG versus LA in women with endometriosis-related pain was assessed for outcomes such as responder rates (using predefined thresholds of pain relief), changes in single symptoms/signs and sum scores from the Biberoglu and Behrman (B&B) scale, clinical laboratory parameters, and measures of quality of life. Results Dienogest was non-inferior to LA for treatment response using all predefined thresholds of pain relief and provided equivalent improvements in B&B symptoms and signs. No clinically relevant changes in laboratory parameters were observed during DNG treatment, whereas estrogen levels decreased in the LA group. Compared with LA, DNG was associated with pronounced improvements in specific quality-of-life measures. Conclusion The analyses provide supportive evidence that the efficacy of DNG is equivalent to that of LA for treating endometriosis symptoms, with specific quality-of-life benefits and a favorable safety profile.