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

Tracking Information

First Received Date ^ICMJE

February 21, 2006

Last Updated Date

August 11, 2008

Start Date ^ICMJE

February 2006

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00296413 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Study Arms / Comparison Groups

Valproate monotherapy
Valproate monotherapy with combined oral contraceptive
Lamotrigine monotherapy
Lamotrigine monotherapy with combined oral contraceptive

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2009

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

13 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andrew G. Herzog, M.D., M.Sc.	617-667-0264
Contact: Kristen Fowler, MA	617-667-0264	kfowler@bidmc.harvard.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00296413

Responsible Party

Andrew G. Herzog, MD, Beth Israel Deaconess Medical Center

Study ID Numbers ^ICMJE

2005-P-000379

Study Sponsor ^ICMJE

Beth Israel Deaconess Medical Center

Collaborators ^ICMJE

Rhode Island Hospital

Investigators ^ICMJE

Principal Investigator:

Andrew G. Herzog, M.D., M.Sc.

Beth Israel Deaconess Medical Center

Information Provided By

Beth Israel Deaconess Medical Center

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP