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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296413
First Posted: February 27, 2006
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rhode Island Hospital
Information provided by (Responsible Party):
Andrew Herzog, Beth Israel Deaconess Medical Center
  Purpose
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
Epilepsy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Andrew Herzog, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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 ]
  • 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

Estimated Enrollment: 48
Study Start Date: February 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Valproate monotherapy
2
Valproate monotherapy with combined oral contraceptive
3
Lamotrigine monotherapy
4
Lamotrigine monotherapy with combined oral contraceptive

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.
  Eligibility

Information from the National Library of Medicine

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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
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
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
Principal Investigator: Andrew G. Herzog, M.D., M.Sc. Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00296413     History of Changes
Other Study ID Numbers: 2005P000379
First Submitted: February 21, 2006
First Posted: February 27, 2006
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:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Contraceptive Agents
Contraceptives, Oral
Lamotrigine
Valproic Acid
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Enzyme Inhibitors
GABA Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs