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

This study has been completed.
Sponsor:
Collaborator:
Rhode Island Hospital
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00296413
First received: February 21, 2006
Last updated: March 15, 2010
Last verified: March 2010
  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 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   13 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Andrew G. Herzog, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00296413     History of Changes
Other Study ID Numbers: 2005-P-000379
Study First Received: February 21, 2006
Last Updated: March 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Contraceptives, Oral, Combined
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Contraceptive Agents, Female
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014