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

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00179426
Collaborator
GlaxoSmithKline (Industry)
175
Enrollment
1
Location
80
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Time Perspective:
    Other
    Official Title:
    Antiseizure Medication-Induced Elevation of Serum Estradiol and Reproductive Dysfunction in Men With Epilepsy
    Study Start Date :
    Oct 1, 1999
    Study Completion Date :
    Jun 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center
      ClinicalTrials.gov Identifier:
      NCT00179426
      Other Study ID Numbers:
      • 2001P000596
      First Posted:
      Sep 16, 2005
      Last Update Posted:
      Mar 13, 2017
      Last Verified:
      Mar 1, 2017
      Keywords provided by Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center
      Seizure Disorder
      Hypogonadism
      Sexual Function
      Epilepsy
      Additional relevant MeSH terms:
      Epilepsy
      Seizures

      Study Results

      No Results Posted as of Mar 13, 2017