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.

4.3 Exposure–response for safety While the exposure–unbound E2 relationship showed a trend of lower E2 with increasing vilaprisan exposure, the E2 concentrations mostly remained within the physiologic range for the follicular phase and E2 levels returned to baseline for all patients in both ASTEROID 1 8 and ASTEROID 2. 9 Although a decrease in E2 levels will contribute to ovulation inhibition and consequently to induction of amenorrhoea, 6 the potential effect of a decrease in E2 levels on long‐term safety is considered to be of higher clinical relevance.

also in 53,322 other papers