Premium
A dose‐ranging study to determine the efficacy and safety of 1, 2, and 4 mg of dienogest daily for endometriosis
Author(s) -
Köhler Günter,
Faustmann Thomas A.,
Gerlinger Christoph,
Seitz Christian,
Mueck Alfred O.
Publication year - 2010
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2009.08.020
Subject(s) - dienogest , medicine , endometriosis , discontinuation , adverse effect , urology , randomized controlled trial , laparoscopy , surgery
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 χ 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.