Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap

Summary

The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.

Timeline

Start

2014-05-15

Primary completion

2016-05-04

Completion

2016-05-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); VPR 4 mg vs Placebo; Percentage difference 58.28 (95% CI 44.55 to 70.94) NCT02131662 ↗

registry analysis (superiority or other test); VPR 2 mg vs Placebo; Percentage difference 52.37 (95% CI 38.8 to 65.42) NCT02131662 ↗

registry analysis (superiority or other test); VPR 1 mg vs Placebo; Percentage difference 54.01 (95% CI 40.41 to 66.95) NCT02131662 ↗

registry analysis (superiority or other test); VPR 0.5 mg vs Placebo; Percentage difference 28.28 (95% CI 15.92 to 41.5) NCT02131662 ↗

Publications

• Ren X, Xia J. An algorithm for computing profile likelihood based pointwise confidence intervals for nonlinear dose-response models. PLoS One. 2019 Jan 25;14(1):e0210953. doi: 10.1371/journal.pone.0210953. eCollection 2019.
• Bradley LD, Singh SS, Simon J, Gemzell-Danielsson K, Petersdorf K, Groettrup-Wolfers E, Ren X, Zvolanek M, Seitz C. Vilaprisan in women with uterine fibroids: the randomized phase 2b ASTEROID 1 study. Fertil Steril. 2019 Feb;111(2):240-248. doi: 10.1016/j.fertnstert.2018.10.012. Epub 2018 Dec 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vilaprisan	Other / unclassified	0.5 mg	Oral
Subject	Vilaprisan	Other / unclassified	1 mg	Oral
Subject	Vilaprisan	Other / unclassified	2 mg	Oral
Subject	Vilaprisan	Other / unclassified	4 mg	Oral

Indications