A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best

Phase 2 Terminated 121 enrolled Bayer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.

Timeline

Start: 2017-11-30
Primary completion: 2018-07-23
Completion: 2018-10-22

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped: “Study BAY1128688/17472 (AKRENDO 1) was terminated early on 20 July 2018 due to hepatotoxicity”

paper The reduced number of valid trial completers precludes conclusions regarding treatment efficacy. PMID 37422772 ↗

Publications

Hilpert J, Groettrup-Wolfers E, Kosturski H, Bennett L, Barnes CLK, Gude K, Gashaw I, Reif S, Steger-Hartmann T, Scheerans C, Solms A, Rottmann A, Mao G, Chapron C. Hepatotoxicity of AKR1C3 Inhibitor BAY1128688: Findings from an Early Terminated Phase IIa Trial for the Treatment of Endometriosis. Drugs R D. 2023 Sep;23(3):221-237. doi: 10.1007/s40268-023-00427-5. Epub 2023 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BAY1128688	Unknown	3 mg	Oral
Subject	BAY1128688	Unknown	10 mg	Oral
Subject	BAY1128688	Unknown	30 mg	Oral
Subject	BAY1128688	Unknown	60 mg	Oral