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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

13 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

Rhode Island Hospital

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Feb 27, 2006
Registry last updated: Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed