NCT00179426

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

First QC Date

September 12, 2005

Last Update Submit

March 9, 2017

Conditions

Keywords

Seizure DisorderHypogonadismSexual FunctionEpilepsy

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must be a male between 18-50 years of age
  • Must have seizures
  • Must be on antiseizure medication for at least six months duration

You may not qualify if:

  • Must not have taken hormones, major tranquilizers or antidepressants for at least 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

EpilepsyHypogonadism

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Andrew G. Herzog, M.D., M.Sc.

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

October 1, 1999

Study Completion

June 1, 2006

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations