Verträglichkeit von Dienogest in der Endometriosetherapie: Analyse gepoolter Daten aus dem klinischen Entwicklungsprogramm

In: Geburtshilfe und Frauenheilkunde · 2011 · vol. 71(10) · doi:10.1055/s-0031-1292712 · W2313251199
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AI-generated summary by claude@2026-06, 2026-06-07

Pooled data from the dienogest clinical development program demonstrate good overall tolerability and a favorable side effect profile for dienogest 2 mg/d in endometriosis therapy.

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

The paper pools data from four clinical development studies of dienogest 2 mg/day in 332 women with confirmed endometriosis, assessing adverse events, laboratory values, vital signs, body weight, and bleeding patterns over up to 65 weeks. It reports good overall tolerability with low rates of adverse events leading to discontinuation, with the most frequent adverse reactions being headache (9.0%), acne (5.1%), and nausea (4.2%). Unlike the GnRH agonist leuprorelin acetate, dienogest did not show relevant hypoestrogenism-related effects such as decreased mean bone mineral density or increased hot flushes, and it was described as metabolically neutral with minimal weight change. Relevance to endometriosis: This paper is centrally about endometriosis—pooled tolerability and adverse-effect characterization of dienogest used for endometriosis-associated pain.

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Abstract

Einleitung: Im klinischen Entwicklungsprogramm von Dienogest (DNG) wurde die Wirksamkeit und Verträglichkeit von DNG 2mg/d in der Endometriosetherapie nachgewiesen. DNG zeigte sich signifikant wirksamer als Placebo und ebenso wirksam wie ein GnRH-Agonist (Leuprorelinacetat, LA) in der Reduktion von Endometriose-assoziierten Schmerzen. Die kontinuierliche Verbesserung der Symptomatik wurde über einen Behandlungszeitraum von bis zu 15 Monaten nachgewiesen. Die Daten zeigen eine gute allgemeine Verträglichkeit und ein günstiges Nebenwirkungsprofil von DNG. Die Analyse gepoolter Daten eröffnet zusätzliche Möglichkeiten zur Charakterisierung der Verträglichkeit von DNG.

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