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, pla…
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 ei…
BACKGROUND: When comparing active treatments, a non-inferiority (or one-sided equivalence) study design is often used. This design requires the definition of a non-inferiority margin, the threshold value of clinical relevance. In recent stu…
OBJECTIVE: To investigate the efficacy and safety of oral dienogest 2mg compared with placebo in the treatment of endometriosis-associated pelvic pain (EAPP). STUDY DESIGN: This was a 12-week, randomized, double-blind, placebo-controlled, …
BACKGROUND: Dienogest is a selective progestin that has been investigated in a clinical trial programme for the treatment of endometriosis. The current non-inferiority trial compared the efficacy and safety of dienogest against leuprolide a…
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 con…
BACKGROUND: The aim of this paper is to empirically identify a treatment-independent statistical method to describe clinically relevant bleeding patterns by using bleeding diaries of clinical studies on various sex hormone containing drugs.…