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| Sponsored by: |
University of Aarhus |
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00266149 |
Purpose
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.
| Condition | Intervention | Phase |
|
Epilepsy |
Drug: Oral contraception Drug: Lamotrigine |
Phase III |
| Genetics Home Reference related topics: | pyridoxal 5'-phosphate-dependent epilepsy |
| MedlinePlus related topics: | Epilepsy |
| Drug Information available for: | Lamotrigine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study |
| Official Title: | Phase 3: Metabolism of Lamotrigine During Treatment With Oral Contraceptives |
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | May 2005 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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).
Contacts and Locations| Denmark | |||||
| Department of Neurology, Aarhus University Hospital | |||||
| Aarhus, Denmark, 8000 | |||||
| University of Aarhus |
| Principal Investigator: | Jakob Christensen, MD, PhD | Department of Neurology, Aarhus University Hospital, 8000 Aarhus C |
More Information
Danish Medicines Agency 
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| Study ID Numbers: | LMS: j.nr. 2612-2188, EK:j. nr. 20030009 |
| First Received: | December 14, 2005 |
| Last Updated: | April 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00266149 |
| Health Authority: | Denmark: Danish Medicines Agency |
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