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

Beth Israel Lahey Health

Status: Completed

Conditions: Epilepsy

Study type: Observational

Funder types: Other

Identifiers

NCT00296413

2005P000379

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 13 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 4 patient groups

1

Description:

Valproate monotherapy

2

Description:

Valproate monotherapy with combined oral contraceptive

3

Description:

Lamotrigine monotherapy

4

Description:

Lamotrigine monotherapy with combined oral contraceptive