A dose-ranging study to determine the efficacy and safety of 1, 2, and 4 mg of dienogest daily for endometriosis |
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Authors: | Gü nter Kö hler,Thomas A. Faustmann,Christian Seitz |
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Affiliation: | a Department of Gynecology and Obstetrics, University of Greifswald, Greifswald, Germany b Bayer Schering Pharma AG, Global Medical Affairs Women's Healthcare, Berlin, Germany c Bayer Schering Pharma AG, Global Biostatistics, Berlin, Germany d Bayer Schering Pharma AG, Global Clinical Development Women's Healthcare, Berlin, Germany e Center of Endocrinology and Menopause, University Women's Hospital of Tübingen, Tübingen, Germany |
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Abstract: | ObjectivesTo compare the efficacy and safety of dienogest at doses of 1, 2, and 4 mg/day orally in the treatment of endometriosis.MethodsAn 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 χ2 and Wilcoxon signed rank tests.ResultsDienogest 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.ConclusionDienogest at 2 mg once a day is recommended as the optimal dose in future studies of endometriosis. |
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Keywords: | Dienogest Endometriosis Dose finding Pelvic pain Progestins |
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