Status:
COMPLETED
Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Seizure Disorder
Hypogonadism
Eligibility:
MALE
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if treatment using a medication (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a tablet that does not contain any a...
Detailed Description
This is a three-month study where baseline information is collected at the first visit and then each patient is started on treatment with testosterone supplementation and either anastrozole or placebo...
Eligibility Criteria
Inclusion
- Subject must be a male between the ages of 18 and 50 years.
- Subject must have localization-related epilepsy with complex partial and/or secondary generalized seizures.
- Subject will meet criteria for hypogonadism (abnormally low bioactive testosterone levels and abnormally low scores on questionnaires of reproductive and sexual function).
- Subject will have had a normal urogenital and rectal/prostate exam during the year prior to entry.
- Subject will have had documentation of therapeutic range serum AED levels, a normal CBC, and hepatic enzyme (ALT,AST, alkaline phosphatase) levels that are less than twofold elevated during the 6 months prior to entry.
Exclusion
- Subject that has taken hormones, major tranquilizers or antidepressants in the three months prior to entry.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00179517
Start Date
June 1 2001
End Date
April 1 2008
Last Update
July 17 2019
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115