Assessment of the safe and efficacious dose of the selective progesterone receptor modulator vilaprisan for the treatment of patients with uterine fibroids by exposure-response modelling and simulation.
Gabriele SutterMatthias FreiMarcus-Hillert Schultze-MosgauKathrin PetersdorfChristian SeitzBart A PloegerPublished in: British journal of clinical pharmacology (2021)
A 2 mg/day dose was selected for Phase 3 as E-R analyses show this dose results in a close to maximum probability for IA, without any safety concerns noted.