Last updated: 11/07/2018 17:23:51
An open-label, non-randomised, single-sequence study to investigate the effects of the combined oral contraceptive pill on the pharmacokinetics of lamotrigine and the effects of lamotrigine on the pharamcokinetics of the combined oral contraceptive pill in healthy young female subjects..
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open-label, non-randomised, single-sequence study to investigate the effects of the combined oral contraceptive pill on the pharmacokinetics of lamotrigine and the effects of lamotrigine on the pharamcokinetics of the combined oral contraceptive pill in healthy young female subjects..
Trial description: An open-label, non-randomised, single-sequence study to investigate the effects of the combined oral contraceptive pill on the pharmacokinetics of lamotrigine and the effects of lamotrigine on the pharamcokinetics of the combined oral contraceptive pill in healthy young female subjects..
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: A bi-directional pharmacokinetic interaction study of lamotrigine and the combined oral contraceptive (coc) pill in healthy subjects. Blum, D., Sidhu, J., Bulsara, S., Job, S., and Philipson, R. 24th American Pain Society Annual Scientific Meeting 3/30/2005 Boston, MA; USA
Abstract: A bi-directional pharmacokinetic interaction study of lamotrigine and the combined oral contraceptive (coc) pill in healthy subjects. Sidhu, Jagdev, Bulsara, Sunita, Job, Sarah, Leadbetter, Robert, and Philipson, Richard 17th Annual U.S. Psychiatric and Mental Health Congress 11/18/2004 San Diego, CA; USA
Abstract: A pharmacokinetic study-lamotrigine and combined oral contraceptive. Sidhu, Jagdev Ph. D., Job, Sarah M. Sc., Bulsara, Sunita B. Sc., and Philipson, Richard M. B. B. s M. R. C. P 45th Annual Meeting of the New Clinical Drug Evaluation Unit (NCDEU) 6/6/2005 Boca Raton, FL; USA
Abstract: The interaction between lamotrigine and a combined oral contraceptive. Sidhu, Jagdev Ph. D., Job, Sarah M. S. C., Bulsara, Sunita B. S. C., and Philipson, Richard B. S. C. 158th Annual Meeting of the American Psychiatric Association 5/21/2005 Atlanta, GA; USA
Blum D, Sidhu J Bulsara S Job S Philipson R A bi-directional pharmacokinetic interaction study of lamotrigine and the combined oral contraceptive (COC) pill in healthy subjects J. PAIN 2005;6(3 SUPPL.1):S83 Abs No 901.
Messenheimer JA Sidhu JS Bulsara SP Job S Philipson RS Pharmacokinetics and hormonal effects of lamotrigine-combined oral contraceptive co-administration.NEUROLOGY 2005;64(6 SUPPL. 1):A427-A428 Abs No S62.004.
Sidhu J Bulsara S Job S Leadbetter R Phillipson R.A bi-directional pharmacokinetic interaction study of lamotrigine and the combined oral contraceptive pill in healthy subjects.NEUROPSYCHOPHARMACOLOGY 2004;29 SUPPL. 1:S124 Abs No 159.
Sidhu J, Bulsara S, Job S, et. al. A BI-DIRECTIONAL PHARMACOKINETIC INTERACTION STUDY OF LAMOTRIGINE AND THE COMBINED ORAL CONTRACEPTIVE PILL IN HEALTHY SUBJECTS presented at the American Epilepsy Society Meeting, 3 - 7 December, 2004, New Orleans, Louisiana
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
June 2003 to December 2003
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-19-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website