drugset / Trial / NCT03557619

A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies

NCT03557619

Phase 1 Recruiting 12 enrolled AbbVie
NaSingle-groupOpen-labelBasic science

Summary

A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study.

Timeline

Start
2019-07-30
Primary completion
2026-03-21
Completion
2026-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Levonorgestrel Small molecule Oral
Subject Venetoclax Small molecule Oral
Subject ethinyl estradiol Small molecule Oral