Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
Completed · Phase 2 · Has a placebo group
Conditions studied: Seizure Disorder, Hypogonadism, Erectile Dysfunction
In brief
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 active medication, when combined with testosterone replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole, the medication that is currently under study, does not, at this time, have FDA approval for use for this indication.
Key facts
- Study ID
- NCT00179517
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 40
- Starts
- 2001-06-01
- Expected to finish
- 2008-04-01
- Last updated by the study team
- 2019-07-17
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Subject that has taken hormones, major tranquilizers or antidepressants in the three months prior to entry.
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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