This Study Tests in Healthy Korean Women Which Effects BI 409306 and a Birth-control Pill Have on Each Other

NCT03193307 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-13

Study results available
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Summary

The primary objective of this trial is to investigate the effect of multiple doses of ethinylestradiol / levonorgestrel (Microgynon®) on single dose pharmacokinetics of BI 409306 and the effect of single dose of BI 409306 on multiple dose pharmacokinetics of ethinylestradiol / levonorgestrel (Microgynon®)

Conditions

  • Healthy

Interventions

DRUG

Microgynon® 30

Run in period \& Treatment Period

DRUG

BI 409306

Day 18 \& 29 (Treatment Period)

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • South Korea

Study Locations

More Related Trials

Entities

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 NCT03193307 on ClinicalTrials.gov