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A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive

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ClinicalTrials.gov Identifier: NCT00296413
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
Rhode Island Hospital
Information provided by (Responsible Party):
Andrew Herzog, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.

Condition or disease
Epilepsy

Detailed Description:
Participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.
Study Design
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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use
Study Start Date : February 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Groups and Cohorts
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Group/Cohort
1
Valproate monotherapy
2
Valproate monotherapy with combined oral contraceptive
3
Lamotrigine monotherapy
4
Lamotrigine monotherapy with combined oral contraceptive


Outcome Measures
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Primary Outcome Measures :
  1. To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels [ Time Frame: 3 years ]
  2. To distinguish any apparent COC effects from the potential effects of the naturally occurring high (mid luteal) and low (early follicular, menstrual) steroid phases of the menstrual cycle itself [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
Serum Samples for hormone testing

Eligibility Criteria
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Ages Eligible for Study:   13 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Two regional epilepsy centers
Criteria

Inclusion Criteria:

  • Must be a female between 13-45 years of age
  • Must have a history of seizures
  • Must be taking either lamotrigine (Lamictal) or valproate (Depakote) with or without a birth control pill

Exclusion Criteria:

  • Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296413


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Rhode Island Hospital
Investigators
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Principal Investigator: Andrew G. Herzog, M.D., M.Sc. Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00296413    
Other Study ID Numbers: 2005P000379
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Keywords provided by Andrew Herzog, Beth Israel Deaconess Medical Center:
epilepsy
menstrual cycle
valproate
lamotrigine
oral contraceptive
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases