drugset / Trial / NCT03342859

Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned

NCT03342859 ↗

Phase 1 Terminated 10 enrolled Bayer
Non-randomizedParallel-groupOpen-labelOther

Summary

To investigate the clinical effects of vilaprisan and ulipristal acetate at molecular and cellular level on uterine and fibroid tissue taken from patients (after surgery / biopsy)

Timeline

Start
2017-11-16
Primary completion
2018-12-17
Completion
2020-01-13

Outcome

Outcome not reported

Stopped: “Due to findings in the preclinical carcinogenicity studies for vilaprisan (BAY1002670)”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ulipristal Acetate Unknown 5 mg Oral
Subject Vilaprisan Other / unclassified 2 mg Oral

Indications