Overview

Lamotrigine and Oral Contraceptives

Status:
Terminated
Trial end date:
2005-05-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Aarhus
Treatments:
Anticonvulsants
Contraceptive Agents
Contraceptives, Oral
Lamotrigine
Criteria
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).