Effect of Antiseizure Medication on Hormone Levels and Sexual Function in Men With Epilepsy

This study has been completed.

Sponsors and Collaborators:	Beth Israel Deaconess Medical Center GlaxoSmithKline
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00179426

Purpose

The purpose of this study is to determine if antiseizure drugs affect hormone levels and sexual function in men with seizures.

Condition
Seizure Disorder Epilepsy

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Official Title:	Antiseizure Medication-Induced Elevation of Serum Estradiol and Reproductive Dysfunction in Men With Epilepsy

Further study details as provided by Beth Israel Deaconess Medical Center:

Estimated Enrollment:	175
Study Start Date:	October 1999
Estimated Study Completion Date:	June 2006

Detailed Description:

This study involves donating two small tubes of blood for hormonal testing, which will be drawn at the same time as your routine blood draw for the monitoring of your antiseizure medication. You will also be asked to fill out a short confidential questionnaire regarding your sexual interest and function.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must be a male between 18-50 years of age
Must have seizures
Must be on antiseizure medication for at least six months duration

Exclusion Criteria:

Must not have taken hormones, major tranquilizers or antidepressants for at least 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179426

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

GlaxoSmithKline

Investigators

Principal Investigator:

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

Beth Israel Deaconess Medical Center

More Information

Publications of Results:

Herzog AG, Drislane FW, Schomer DL, Pennell PB, Bromfield EB, Kelly KM, Farina EL, Frye CA. Differential effects of antiepileptic drugs on sexual function and reproductive hormones in men with epilepsy: interim analysis of a comparison between lamotrigine and enzyme-inducing antiepileptic drugs. Epilepsia. 2004 Jul;45(7):764-8.

Study ID Numbers:	2001-P-000596
Study First Received:	September 12, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00179426
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Seizure Disorder
Hypogonadism
Sexual Function
Epilepsy

Study placed in the following topic categories:

Hypogonadism
Epilepsy
Estradiol 3-benzoate
Estradiol valerate
Seizures

Central Nervous System Diseases
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Brain Diseases
Estradiol

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009