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Vilaprisan for the treatment of symptomatic endometriosis: results from a terminated phase 2b randomized controlled trial.
F S Rep
June 2024
Bayer AG, Berlin, Germany.
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 (NCT03573336).
Efficacy and safety of vilaprisan in women with uterine fibroids: data from the ASTEROID 3 randomized controlled trial.
F S Sci
November 2023
Bayer AG, Berlin, Germany; Institute of Clinical Pharmacology and Toxicology, Universitätsmedizin Berlin, Berlin, Germany. Electronic address:
Objective: Vilaprisan is a highly potent selective progesterone receptor modulator shown to reduce heavy menstrual bleeding, induce amenorrhea, and diminish uterine fibroid volume in phase 2 studies. The objective of ASTEROID 3 was to demonstrate the superiority of vilaprisan compared with placebo in the treatment of heavy menstrual bleeding in women with uterine fibroids.
Design: Randomized, double-blind, placebo-controlled, multicenter phase 3 study.
Research advances in drug therapy of endometriosis.
Front Pharmacol
June 2023
Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.
Endometriosis is one of the most common benign gynecological disorders in reproductive-aged women. The major symptoms are chronic pelvic pain and infertility. Despite its profound impact on women's health and quality of life, its pathogenesis has not been fully elucidated, it cannot be cured and the long-term use of drugs yields severe side effects and hinders fertility.
View Article and Find Full Text PDFBackground: Uterine fibroids constitute a significant health problem in the United States, affecting upward of 11 million people.
Objective: Characterize the literature regarding the incidence of amenorrhea and reductions in abnormal uterine bleeding and fibroid size and to report on clinically relevant safety outcomes of oral medications that may be used to manage symptomatic uterine fibroids to assist in choice of therapeutic options.
Methods: A literature search was conducted through December 31, 2021, using Embase, MEDLINE, and International Pharmaceutical Abstracts databases.
Clinical Pharmacokinetics and Pharmacodynamics of the Selective Progesterone Receptor Modulator Vilaprisan: A Comprehensive Overview.
Clin Pharmacokinet
January 2022
Drug Metabolism and Pharmacokinetics, Bayer AG, Berlin, Germany.
Vilaprisan is a highly potent selective progesterone receptor modulator in development for the treatment of symptomatic uterine fibroids and endometriosis. Its pharmacokinetics are characterized by rapid absorption, almost complete bioavailability, and dose-proportional exposure. The intrinsic factors of age, bodyweight, and race have no clinically relevant effect on the pharmacokinetics and pharmacodynamics of vilaprisan and do not warrant a dose adjustment.
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