NCT05613777

A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood

The Effect of Multiple Doses of BI 425809 on the Pharmacokinetics of Multiple Doses of a Combination of Ethinylestradiol and Levonorgestrel Following Oral Administration in Healthy Premenopausal Female Subjects (an Open-label, Two-period, Fixed Sequence Design Trial With run-in Period)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate the possible effect of multiple oral doses of BI 425809 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (administered as the combined oral contraceptive Microgynon®).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Microgynon®	ethinylestradiol (EE) and levonorgestrel (LNG)
DRUG	BI 425809	BI 425809

Timeline

• Start date: 2022-11-24
• Primary completion: 2023-10-04
• Completion: 2023-10-04
• First posted: 2022-11-14
• Last updated: 2023-10-19

Locations

1 site across 1 country: Germany