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

Günter Köhler, Thomas A Faustmann, Thomas Faustmann, Christoph Gerlinger, Christian Seitz, Alfred O Mueck
International Journal of Gynecology & Obstetrics · 2009 · vol. 108(1) , pp. 21–25 · doi:10.1016/j.ijgo.2009.08.020 · PMID:19819448 · W2002840726
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This study found that daily oral dienogest at 2mg and 4mg improved endometriosis lesions and symptoms, with both doses generally well tolerated, unlike the 1mg dose which was discontinued for insufficient bleeding control.

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Abstract

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.

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Condition tags

mesh:D004715endometriosis

MeSH descriptors

Endometriosis Hormone Antagonists Nandrolone Adult Dose-Response Relationship, Drug Endometriosis Female Fertility Fertility Hormone Antagonists Hormone Antagonists Hormone Antagonists Humans Laparoscopy Nandrolone Nandrolone Nandrolone Nandrolone Statistics, Nonparametric Treatment Outcome

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