Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment

Felice Petraglia, Daniela Hornung, Christian Seitz, Thomas Faustmann, Christoph Gerlinger, Stefano Luisi, Lucia Lazzeri, Thomas Strowitzki, T. Strowitzki
Archives of gynecology and obstetrics · 2011 · vol. 285(1) , pp. 167–173 · doi:10.1007/s00404-011-1941-7 · PMID:21681516 · PMC3249203 · W2159474777
article OA: gold CC0 ⤵ 163 in-corpus citations
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⚙ AI-generated summary by claude@2026-06, 2026-06-07 ⓘ

Long-term dienogest treatment reduced pelvic pain and bleeding irregularities in women with endometriosis, with pain relief persisting for at least 24 weeks after treatment cessation.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-07 ⓘ

This multicenter German, Italian, and Ukrainian open-label extension study assessed the long-term efficacy and safety of dienogest 2 mg once daily in women aged 18–45 years with laparoscopically confirmed endometriosis who had previously completed a 12-week placebo-controlled trial, with an additional 24-week treatment-free follow-up in a subgroup. Pelvic pain on a 100-mm visual analog scale and a diary-based bleeding pattern were tracked every 4 weeks, along with adverse events and laboratory parameters. Pelvic pain decreased significantly during continued dienogest treatment, bleeding frequency and intensity progressively declined, and most adverse events were mild or moderate, with withdrawal in 2.4%; no clinically relevant laboratory changes were observed, and the pain reduction persisted for at least 24 weeks after stopping. A key limitation is that the extension design was not randomized and the treatment-free follow-up included only a subgroup (n = 34), restricting comparative conclusions. This paper is centrally about endometriosis — long-term dienogest treatment for sustained reductions in pelvic pain and bleeding patterns, including follow-up after discontinuation.

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Abstract

PURPOSE: To 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. METHODS: A 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. RESULTS: The 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. CONCLUSIONS: Long-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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Condition tags

endometriosischronic_pelvic_pain

MeSH descriptors

Endometriosis Hormone Antagonists Nandrolone Adolescent Adult Drug Administration Schedule Endometriosis Female Follow-Up Studies Germany Hormone Antagonists Humans Italy Middle Aged Nandrolone Nandrolone Pelvic Pain Ukraine Young Adult

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