Lamotrigine and Oral Contraceptives

This study has been terminated.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00266149
First received: December 14, 2005
Last updated: April 23, 2008
Last verified: December 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 3: Metabolism of Lamotrigine During Treatment With Oral Contraceptives

Resource links provided by NLM:


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
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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

Additional Information:
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.

ClinicalTrials.gov Identifier: NCT00266149     History of Changes
Other Study ID Numbers: LMS: j.nr. 2612-2188, EK:j. nr. 20030009
Study First Received: December 14, 2005
Last Updated: April 23, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Pharmacokinetics
Lamotrigine
Oral Contraceptives
UGT
Glucuronidation.

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Contraceptive Agents
Contraceptives, Oral
Lamotrigine
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014