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

Sponsor:	Beth Israel Deaconess Medical Center
Collaborator:	Rhode Island Hospital
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00296413

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:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Menstruation

Drug Information available for: Divalproex sodium Lamotrigine Valproic acid Valproate Sodium

U.S. FDA Resources

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

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
Lamotrigine
Valproic Acid
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012