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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179426
First Posted: September 16, 2005
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Andrew Herzog, Beth Israel Deaconess Medical Center
  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: Time Perspective: Other
Official Title: Antiseizure Medication-Induced Elevation of Serum Estradiol and Reproductive Dysfunction in Men With Epilepsy

Resource links provided by NLM:


Further study details as provided by Andrew Herzog, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179426     History of Changes
Other Study ID Numbers: 2001P000596
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Andrew Herzog, 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