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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296413
• Other study ID #: 2005P000379
• Status: Completed
• Phase: N/A
• First received: February 21, 2006
• Last updated: March 10, 2017
• Start date: February 2006
• Est. completion date: February 2009

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

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