NCT00266149

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
Last Updated

April 24, 2008

Status Verified

December 1, 2005

First QC Date

December 14, 2005

Last Update Submit

April 23, 2008

Conditions

Epilepsy

Keywords

PharmacokineticsLamotrigineOral ContraceptivesUGTGlucuronidation.

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Interventions

Oral contraceptionDRUG
LamotrigineDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

Related Publications (5)

  • 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. doi: 10.1111/j.0013-9580.2004.06304.x.

    PMID: 15101822BACKGROUND

  • 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. doi: 10.1111/j.0013-9580.2004.06204.x.

    PMID: 15101821BACKGROUND

  • 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. doi: 10.1016/s1474-4422(03)00409-5.

    PMID: 12849151BACKGROUND

  • 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. doi: 10.1038/clpt.1990.162.

    PMID: 2225696BACKGROUND

  • Shipkova M, Wieland E. Glucuronidation in therapeutic drug monitoring. Clin Chim Acta. 2005 Aug;358(1-2):2-23. doi: 10.1016/j.cccn.2005.02.023.

    PMID: 15893300BACKGROUND

Related Links

MeSH Terms

Conditions

Epilepsy

Interventions

Contraceptives, OralLamotrigine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesTriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jakob Christensen, MD, PhD

    Department of Neurology, Aarhus University Hospital, 8000 Aarhus C

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Study Start

June 1, 2003

Study Completion

May 1, 2005

Last Updated

April 24, 2008

Record last verified: 2005-12

Locations

DK(1)