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

International journal of gynaecology and obstetrics: the official organ of the International Federat 2009 Oct 9; In press

Link to PubMed abstract

Köhler G, Faustmann T TA, Gerlinger C, Seitz C, Mueck A AO

Department of Gynecology and Obstetrics, University of Greifswald, Greifswald, Germany.

OBJECTIVES: To compare the efficacy and safety of dienogest at doses of 1, 2, and 4mg/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 4mg/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 2mg once a day is recommended as the optimal dose in future studies of endometriosis.

Keywords: endometriosis