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

International Journal of Gynecology & Obstetrics - Tập 117 - Trang 228-233 - 2012
Thomas Strowitzki1, Joachim Marr2, Christoph Gerlinger3, Thomas Faustmann4, Christian Seitz2
1Department of Gynecological Endocrinology and Reproductive Medicine, University of Heidelberg, Vossstrasse 9, 69115 Heidelberg, Germany
2Global Clinical Development, Women's Healthcare, Bayer HealthCare, Berlin, Germany
3Global Biostatistics, Women's Healthcare, Bayer HealthCare, Berlin, Germany
4Global Medical Affairs, Women's Healthcare, Bayer HealthCare, Berlin, Germany

Tóm tắt

AbstractObjectiveTo analyze the secondary efficacy and safety outcomes from a recent trial comparing dienogest (DNG) with leuprolide acetate (LA) in women with endometriosis.MethodsA 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.ResultsDienogest 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.ConclusionThe 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.

Tài liệu tham khảo

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Thông tin xuất bản

International Journal of Gynecology & Obstetrics

Tập 117

228-233

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