Status:
TERMINATED
Lamotrigine and Oral Contraceptives
Lead Sponsor:
University of Aarhus
Conditions:
Epilepsy
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
The present study evaluates the effect of oral contraceptives on lamotrigine plasma concentrations in a double blind, placebo controlled, cross-over study in patients with epilepsy.
Detailed Description
Lamotrigine is widely used as an antiepileptic drug in the treatment of newly onset as well as refractory epilepsy (1;2). Lamotrigine is unique among the antiepileptic drug since the major route (76%)...
Eligibility Criteria
Inclusion
- Women with epilepsy, treated with lamotrigine in monotherapy and taking combination type oral contraceptives, and who were between 18 and 40 years of age, were candidates for inclusion in the study. Patients should agree to use contraception of barrier type throughout the study (see study design).
Exclusion
- Patients were not admitted to the study if any of the following criteria were present: (1) pregnancy, (2) breastfeeding, (3) affected liver function, (4) affected kidney function, (5) daily intake of drugs with known or suspected influence on the metabolism of lamotrigine (acetaminophen and sertralin).
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00266149
Start Date
June 1 2003
End Date
May 1 2005
Last Update
April 24 2008
Active Locations (1)
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1
Department of Neurology, Aarhus University Hospital
Aarhus, Aarhus, Denmark, 8000