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

Condition(s) targeted: Epilepsy

Phase: N/A

Status: Completed

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Andrew G. Herzog, M.D., M.Sc., Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

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.

Official title: Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels

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

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.

Minimum age: 13 Years. Maximum age: 45 Years. Gender(s): Female.

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

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Starting date: February 2006
Last updated: March 15, 2010