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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00296413

Enrollment

Registered

2006-02-27

Start date

2006-02-28

Completion date

2009-02-28

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

epilepsy, menstrual cycle, valproate, lamotrigine, oral contraceptive

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

13 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels	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	3 years

Countries

United States

Outcome results