At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 19 enrolled
Drug / intervention
Microgynon® +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.
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)
In Brief
A Phase 1 clinical trial evaluating Microgynon® and Iclepertin for Healthy. Completed, enrolled 19 participants across 1 site.
Detailed 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®).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedNov 2022
Enrollment StartNov 2022
Primary CompletionOct 2023
TodayJul 2026
First PostedNov 14, 2022
Enrollment StartNov 24, 2022
Primary CompletionOct 4, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.6 years ago
Interventions
Microgynon®drug
ethinylestradiol (EE) and levonorgestrel (LNG)
Iclepertindrug
Iclepertin