At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
levonorgestrel +4 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.
An Open-label, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of 240 mg BI 201335 QD on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers
In Brief
A Phase 1 clinical trial evaluating levonorgestrel, Ethinylestradiol, and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 16 participants across 1 site.
Detailed Summary
This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionAug 2012
TodayJul 2026
First PostedApr 4, 2012
Enrollment StartApr 1, 2012
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.2 years ago
Interventions
levonorgestreldrug
multiple doses
Ethinylestradioldrug
multiple doses
levonorgestreldrug
multiple doses
BI 201335drug
multiple doses
Ethinylestradioldrug
multiple doses