Thomas Faustmann

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…

Introduction: Women with endometriosis require individualized, long-term treatment. Analyzing prescription choices, medication switches, discontinuations, and breaks can describe real-world treatment patterns and optimize pathways for women…

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…

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 …

OBJECTIVE: To harmonize standard operating procedures (SOPs) and standardize the recording of associated data for collection, processing, and storage of human tissues relevant to endometriosis. DESIGN: An international collaboration involvi…

OBJECTIVE: To harmonize the collection of nonsurgical clinical and epidemiologic data relevant to endometriosis research, allowing large-scale collaboration. DESIGN: An international collaboration involving 34 clinical/academic centers and …

OBJECTIVE: To harmonize standard operating procedures (SOPs) and standardize the recording of associated data for collection, processing, and storage of fluid biospecimens relevant to endometriosis. DESIGN: An international collaboration in…

STUDY QUESTION: Is there a global consensus on the management of endometriosis that considers the views of women with endometriosis? SUMMARY ANSWER: It was possible to produce an international consensus statement on the current management o…

Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

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…

Purpose The aim of our work was to explore which of the most commonly used pain scales is best suited to assess treatment success in endometriosis therapy and, therefore, qualifies best to be used as primary endpoint for clinical studies in…

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…

The authors wish to clarify that analyses in the paper are based on the full-analysis set (FAS), excluding patients for whom data were unavailable. For the revised American Fertility Society (rAFS) score, data were unavailable in 9.5% of pa…

Purpose The symptoms of endometriosis are heterogeneous and overlap with those of other conditions, resulting in misdiagnoses and/or delayed diagnosis and treatment. The Uterine Bleeding and Pain Women's Research Study (UBP-WRS) collected d…

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…

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…

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 conf…