A dose-ranging study to determine the efficacy and safety of 1, 2, and 4 mg of dienogest daily for endometriosis

被引:104
作者
Koehler, Guenter [1 ]
Faustmann, Thomas A. [2 ]
Gerlinger, Christoph [3 ]
Seitz, Christian [4 ]
Mueck, Alfred O. [5 ]
机构
[1] Ernst Moritz Arndt Univ Greifswald, Klin & Poliklin Frauenheilkunde & Geburtshilfe, Dept Gynecol & Obstet, D-17489 Greifswald, Germany
[2] Bayer Schering Pharma AG, Global Med Affairs Womens Healthcare, Berlin, Germany
[3] Bayer Schering Pharma AG, Global Biostat, Berlin, Germany
[4] Bayer Schering Pharma AG, Global Clin Dev Womens Healthcare, Berlin, Germany
[5] Univ Womans Hosp Tubingen, Ctr Endocrinol & Menopause, Tubingen, Germany
关键词
Dienogest; Endometriosis; Dose finding; Pelvic pain; Progestins; PROGESTIN DIENOGEST; LIPID-METABOLISM; PAIN;
D O I
10.1016/j.ijgo.2009.08.020
中图分类号
R71 [妇产科学];
学科分类号
100211 [妇产科学];
摘要
Objectives: To compare the efficacy and safety of dienogest at doses of 1, 2, and 4 mg/day orally in the treatment of endometriosis. Methods: An open-label, randomized, multicenter, 24-week comparative trial in women with histologically confirmed endometriosis. Efficacy was assessed by second-look laparoscopy and patient-reported symptoms. Statistical tests included chi(2) and Wilcoxon signed rank tests. Results: Dienogest reduced mean revised American Fertility Society scores from 11.4 to 3.6 (n=29; P<0.001) in the 2-mg group and from 9.7 to 3.9 (n=35; P<0.001) in the 4-mg group. Dienogest at 2 and 4 mg/day was associated with symptom improvements in substantial proportions of women. Both dienogest doses were generally well tolerated, with low rates of treatment discontinuation due to adverse events. The 1-mg dose arm was discontinued owing to insufficient bleeding control. Conclusion: Dienogest at 2 mg once a day is recommended as the optimal dose in future studies of endometriosis. (C) 2009 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
引用
收藏
页码:21 / 25
页数:5
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