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

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT00179426

First received: September 12, 2005

Last updated: September 7, 2006

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 7, 2006

Start Date ^ICMJE

October 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00179426 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Antiseizure Medication-Induced Elevation of Serum Estradiol and Reproductive Dysfunction in Men With Epilepsy

Brief Summary

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Seizure Disorder
Epilepsy

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

175

Completion Date

June 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00179426

Other Study ID Numbers ^ICMJE

2001-P-000596

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Beth Israel Deaconess Medical Center

Collaborators ^ICMJE

GlaxoSmithKline

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

September 2005

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

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