Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment
PurposeTo investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an ope...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2012
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| In: |
Archives of gynecology and obstetrics
Year: 2011, Volume: 285, Issue: 1, Pages: 167-173 |
| ISSN: | 1432-0711 |
| DOI: | 10.1007/s00404-011-1941-7 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1007/s00404-011-1941-7 Verlag, Volltext: https://link.springer.com/article/10.1007/s00404-011-1941-7 
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| Author Notes: | Felice Petraglia, Daniela Hornung, Christian Seitz, Thomas Faustmann, Christoph Gerlinger, Stefano Luisi, Lucia Lazzeri, Thomas Strowitzki |
| Summary: | PurposeTo investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation.MethodsA multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment.ResultsThe completion rate among women who entered the open-label extension study was 90.5% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P < 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4%). No clinically relevant changes in laboratory parameters were observed. During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns.ConclusionsLong-term dienogest showed a favorable efficacy and safety profile, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation. |
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| Item Description: | Published online: 17 June 2011 Gesehen am 09.08.2018 |
| Physical Description: | Online Resource |
| ISSN: | 1432-0711 |
| DOI: | 10.1007/s00404-011-1941-7 |