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

NCT ID: NCT00179426

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-10-31

Study Completion Date

2006-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Seizure Disorder Epilepsy

Study Design

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Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Andrew Herzog

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew G. Herzog, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1111/j.0013-9580.2004.60703.x.

Reference Type RESULT
PMID: 15230699 (View on PubMed)

Other Identifiers

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2001P000596

Identifier Type: -

Identifier Source: org_study_id

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