At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Microgynon® 30 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of Ethinylestradiol/Levonorgestrel (Microgynon®) and BI 409306 in Healthy Korean Premenopausal Female Subjects (an Open-label, Two-period, Fixed-sequence Study)
In Brief
A Phase 1 clinical trial evaluating Microgynon® 30 and BI 409306 for Healthy. Completed, enrolled 16 participants across 1 site.
Detailed 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®)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJun 2017
Primary CompletionDec 2017
TodayJul 2026
First PostedJun 20, 2017
Enrollment StartJun 29, 2017
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.0 years ago
Interventions
Microgynon® 30drug
Run in period \& Treatment Period
BI 409306drug
Day 18 \& 29 (Treatment Period)