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

September 12, 2005
September 7, 2006
October 1999
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Complete list of historical versions of study NCT00179426 on ClinicalTrials.gov Archive Site
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Effect of Antiseizure Medication on Hormone Levels and Sexual Function in Men With Epilepsy
Antiseizure Medication-Induced Elevation of Serum Estradiol and Reproductive Dysfunction in Men With Epilepsy

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

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.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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  • Seizure Disorder
  • Epilepsy
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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.
 
Completed
175
June 2006
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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
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179426
2001-P-000596
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Beth Israel Deaconess Medical Center
GlaxoSmithKline
Principal Investigator: Andrew G. Herzog, M.D., M.Sc. Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
September 2005

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