Text Size

Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00898560
First received: May 11, 2009
Last updated: June 18, 2012
Last verified: June 2012
History of Changes

May 11, 2009
June 18, 2012
September 2008
November 2008   (final data collection date for primary outcome measure)
To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). [ Time Frame: 15-day ] [ Designated as safety issue: No ]
To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00898560 on ClinicalTrials.gov Archive Site
To investigate the tolerability of concomitant administration of ESL 800 mg QD and a combined oral contraceptive. [ Time Frame: 15-day ] [ Designated as safety issue: Yes ]
To investigate the tolerability of concomitant administration of ESL 800 mg QD and a combined oral contraceptive. [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive
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

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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Partial Epilepsy
  • Drug: eslicarbazepine acetate and Microginon®

    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

    Other Names:
    • ESL
    • BIA 2-093
  • Drug: Microginon®
    Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
  • Placebo Comparator: Microginon®
    A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
    Intervention: Drug: Microginon®
  • Active Comparator: ESL and Microginon®
    15-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.
    Intervention: Drug: eslicarbazepine acetate and Microginon®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
  • Negative urine pregnancy test at screening and admission to each treatment period.
  • Using one of the following methods of contraception: double barrier or intrauterine device

Exclusion Criteria:

  • 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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT00898560
BIA-2093-128
Yes
Bial - Portela C S.A.
Bial - Portela C S.A.
Not Provided
Principal Investigator: Manuel Vaz-da-Silva Bial Portela
Bial - Portela C S.A.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP