CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 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.

Search/NCT01328184
NCT01328184Phase 1Completed
CompareCT.gov

An Open-label, Two-period, Fixed-sequence Trial to Evaluate the Effect of Multiple Doses of BI 10773 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers

Boehringer Ingelheim·interventional·Posted Apr 4, 2011·Updated Jun 18, 2014

In Brief

A Phase 1 clinical trial evaluating levonorgestrel, Ethinylestradiol, and 1 other intervention for Healthy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2011
Enrollment StartApr 1, 2011
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.2 years ago

Interventions

levonorgestreldrug

multiple doses

levonorgestreldrug

multiple doses

Ethinylestradioldrug

multiple doses

Microgynon + BI 10773drug

multiple doses BI 10773

Ethinylestradioldrug

multiple doses