NCT00296413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

February 21, 2006

Last Update Submit

March 10, 2017

Conditions

Epilepsy

Keywords

epilepsymenstrual cyclevalproatelamotrigineoral contraceptive

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

1

Valproate monotherapy

2

Valproate monotherapy with combined oral contraceptive

3

Lamotrigine monotherapy

4

Lamotrigine monotherapy with combined oral contraceptive

Eligibility Criteria

Age13 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Two regional epilepsy centers

You may qualify if:

  • 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

You may not qualify if:

  • Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Samples for hormone testing

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Andrew G. Herzog, M.D., M.Sc.

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 27, 2006

Study Start

February 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

US(1)