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RECRUITING
NCT03557619
PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2019-07-30

Completion Date

2026-03-21

Last Updated

2024-08-29

Healthy Volunteers

No

Interventions

DRUG

Venetoclax

tablet; oral

DRUG

ethinyl estradiol/levonorgestrel

tablet; oral

Locations (4)

Duplicate_Henry Ford Health System /ID# 209090

Detroit, Michigan, United States

Dartmouth-Hitchcock Medical Center /ID# 169097

Lebanon, New Hampshire, United States

Gabrail Cancer Center Research /ID# 207039

Canton, Ohio, United States

Peter MacCallum Cancer Centre-East Melbourne /ID# 225247

East Melbourne, Victoria, Australia