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

NCT05613777 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-05-06

Study results available
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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

DRUG

Microgynon®

ethinylestradiol (EE) and levonorgestrel (LNG)

DRUG

Iclepertin

Iclepertin

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-24
Primary Completion
2023-10-04
Completion
2023-10-04

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613777 on ClinicalTrials.gov