Trials / Recruiting
RecruitingNCT03557619
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- AbbVie · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Venetoclax | tablet; oral |
| DRUG | ethinyl estradiol/levonorgestrel | tablet; oral |
Timeline
- Start date
- 2019-07-30
- Primary completion
- 2026-03-21
- Completion
- 2026-03-21
- First posted
- 2018-06-15
- Last updated
- 2024-08-29
Locations
4 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03557619. Inclusion in this directory is not an endorsement.