Completed
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
What is being tested
eslicarbazepine acetate and Microginon®
+ Microginon®
Drug
Who is being recruted
Brain Diseases+2
+ Central Nervous System Diseases
+ Epilepsy
From 18 to 40 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: September 2008
Summary
Principal SponsorBial - Portela C S.A.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2008
Actual date on which the first participant was enrolled.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).
Official TitleEffect of Repeated Administration of Eslicarbazepine Acetate (BIA 2-093) 800mg Once-daily on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Subjects
Principal SponsorBial - Portela C S.A.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 18 to 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Brain DiseasesCentral Nervous System DiseasesEpilepsyEpilepsies, PartialNervous System Diseases
Criteria
7 inclusion criteria required to participate
Pre-menopausal female subjects
Age 18-40 years, inclusive
Body mass index (BMI) 19-30 kg/m2, inclusive
Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
Show More Criteria
4 exclusion criteria prevent from participating
Subjects who have any contra-indication to the use of oral contraceptives
History or presence of clinically relevant diseases, disorders or surgical history
History of alcoholism or drug abuse
Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
Group II
A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Human Pharmacology Unit (UFH), Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, S. Mamede do Coronado
Porto, PortugalOpen Human Pharmacology Unit (UFH), Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, S. Mamede do Coronado in Google MapsCompletedOne Study Center