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NCT05613777
PHASE1

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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®).

Official title: 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)

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2022-11-24

Completion Date

2023-10-04

Last Updated

2026-05-06

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Microgynon®

ethinylestradiol (EE) and levonorgestrel (LNG)

DRUG

Iclepertin

Iclepertin

Locations (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, Germany