Faustmann T

Background/Objectives: Vilaprisan and ulipristal acetate (UPA) have demonstrated efficacy in treating uterine fibroids (UFs). However, a direct comparison of vilaprisan and UPA has been restricted, to date, to a small phase 2 study. Here, w…

BackgroundVilaprisan is a selective progesterone receptor modulator with demonstrated efficacy in the management of uterine fibroids (UFs).ObjectivesTo evaluate the safety and efficacy of vilaprisan in Japanese women with UFs and heavy mens…

OBJECTIVE: To evaluate the efficacy and safety of 2 doses of vilaprisan vs. placebo in participants with symptomatic endometriosis. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2b trial (NCT035733…

Endometriosis is a chronic disease that requires a suitable, lifelong treatment. To our knowledge, the Visanne Post-approval Observational Study (VIPOS) is to date the largest real-world, non-interventional study investigating hormonal mana…

Since its introduction in 1990, the levonorgestrel-releasing intrauterine system (LNG-IUS) has played a key role in shaping the healthcare landscape of women. Here we explore the development of the first LNG-IUS (Mirena®) and the early clin…

INTRODUCTION: Endometriosis is a common gynecologic disease associated with a significant burden on women's health and healthcare systems. Currently approved hormonal treatments for endometriosis can be effective in controlling symptoms, bu…

BACKGROUND: In four randomized, controlled, European trials, dienogest 2 mg once daily demonstrated significant efficacy for lesion reduction and reduction in pain intensity in endometriosis. We describe a pooled analysis of the safety and …

Thomas Strowitzki,1 Thomas Faustmann,2 Christoph Gerlinger,3,4 Ulrike Schumacher,5,6 Christiane Ahlers,7 Christian Seitz8 1Department of Gynecological Endocrinology and Reproductive Medicine, University of Heidelberg, Heidelberg, Germany; 2…

OBJECTIVE: To analyze the secondary efficacy and safety outcomes from a recent trial comparing dienogest (DNG) with leuprolide acetate (LA) in women with endometriosis. METHODS: A 24-week, open-label, randomized, multicenter study of DNG ve…

Approaches to the treatment of endometriosis vary worldwide, but studies comparing endometriosis medications in different ethnic groups are rare. A systematic literature search identified two studies directly comparing dienogest (DNG) versu…

Dienogest offers pharmacological advantages for the effective treatment of endometriosis and for use in contraception and hormone replacement therapy. This pharmacodynamic study investigated the ovulation-inhibiting effects of dienogest mon…

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…

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…

ObjectiveTo investigate the efficacy and safety of oral dienogest 2mg compared with placebo in the treatment of endometriosis-associated pelvic pain (EAPP).Study designThis was a 12-week, randomized, double-blind, placebo-controlled, multic…

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…