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NCT00179426 Clinical Trial

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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00179426
Other study ID # 2001P000596
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated March 9, 2017
Start date October 1999
Est. completion date June 2006

Study information
Verified date March 2017
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 175
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

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