CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
eslicarbazepine acetate and Microginon® +1 moredrug
Likely dose
eslicarbazepine acetate and Microginon® 800 mgfrom 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/NCT00898560
NCT00898560Phase 1Completed
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Effect of Repeated Administration of Eslicarbazepine Acetate (BIA 2-093) 800mg Once-daily on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Subjects

Bial - Portela C S.A.·interventional·Posted May 12, 2009·Updated Dec 12, 2014

In Brief

A Phase 1 clinical trial evaluating eslicarbazepine acetate and Microginon® and Microginon® for Partial Epilepsy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Epilepsy
CountriesPortugal
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 12, 2009
Enrollment StartSep 1, 2008
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.1 years ago

Interventions

eslicarbazepine acetate and Microginon®drug

eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period. Microginon®: single oral dose on day 14 of treatment period

Microginon®drug

Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)