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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
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

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:

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

Keywords provided by Beth Israel Deaconess Medical Center:
Seizure Disorder
Hypogonadism
Sexual Function
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013