Lamotrigine and Oral Contraceptives - Full Text View

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

U.S. FDA Resources

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

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

The dose corrected trough concentration of lamotrigine following 21 days of placebo treatment compared to the dose

Secondary Outcome Measures:

Secondary endpoints; the trough concentration of lamotrigine following 7 days of pause with the oral contraceptive pill, and the proportion of lamotrigine to lamotrigine metabolites found in urine samples following treatment with placebo and the o

Estimated Enrollment:	10
Study Start Date:	June 2003
Estimated Study Completion Date:	May 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266149

Locations


Denmark
	Department of Neurology, Aarhus University Hospital
	Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Investigators


Principal Investigator:	Jakob Christensen, MD, PhD	Department of Neurology, Aarhus University Hospital, 8000 Aarhus C

More Information

Danish Medicines Agency This link exits the ClinicalTrials.gov site

Publications:

French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, Harden CL, Theodore WH, Bazil C, Stern J, Schachter SC, Bergen D, Hirtz D, Montouris GD, Nespeca M, Gidal B, Marks WJ Jr, Turk WR, Fischer JH, Bourgeois B, Wilner A, Faught RE Jr, Sachdeo RC, Beydoun A, Glauser TA; American Academy of Neurology Therapeutics and Technology Assessment Subcommittee; American Academy of Neurology Quality Standards Subcommittee; American Epilepsy Society Therapeutics and Technology Assessment Subcommittee; American Epilepsy Society Quality Standards Subcommittee. Efficacy and tolerability of the new antiepileptic drugs, II: Treatment of refractory epilepsy: report of the TTA and QSS Subcommittees of the American Academy of Neurology and the American Epilepsy Society. Epilepsia. 2004 May;45(5):410-23. Review. Erratum in: Epilepsia. 2004 Nov;45(11):1299.

French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, Harden CL, Theodore WH, Bazil C, Stern J, Schachter SC, Bergen D, Hirtz D, Montouris GD, Nespeca M, Gidal B, Marks WJ Jr, Turk WR, Fischer JH, Bourgeois B, Wilner A, Faught RE Jr, Sachdeo RC, Beydoun A, Glauser TA; American Academy of Neurology Therapeutics and Technology Assessment Subcommittee; American Academy of Neurology Quality Standards Subcommittee; American Epilepsy Society Quality Standards Subcommittee; American Epilepsy Society Therapeutics and Technology Assessment Subcommittee. Efficacy and tolerability of the new antiepileptic drugs, I: Treatment of new-onset epilepsy: report of the TTA and QSS Subcommittees of the American Academy of Neurology and the American Epilepsy Society. Epilepsia. 2004 May;45(5):401-9. Review.

Patsalos PN, Perucca E. Clinically important drug interactions in epilepsy: general features and interactions between antiepileptic drugs. Lancet Neurol. 2003 Jun;2(6):347-56. Review.

Depot M, Powell JR, Messenheimer JA Jr, Cloutier G, Dalton MJ. Kinetic effects of multiple oral doses of acetaminophen on a single oral dose of lamotrigine. Clin Pharmacol Ther. 1990 Oct;48(4):346-55.

Shipkova M, Wieland E. Glucuronidation in therapeutic drug monitoring. Clin Chim Acta. 2005 Aug;358(1-2):2-23. Review.

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

Keywords provided by University of Aarhus:

Pharmacokinetics

Lamotrigine

Oral Contraceptives

UGT

Glucuronidation.

Study placed in the following topic categories:

Epilepsy

Lamotrigine

Central Nervous System Diseases

Brain Diseases

Additional relevant MeSH terms:

Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Nervous System Diseases

Calcium Channel Blockers

Cardiovascular Agents

Central Nervous System Agents

Anticonvulsants

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00266149