NCT00179517

Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo

Comparison of Anastrozole and Testosterone Versus Placebo and Testosterone Treatment of Reproductive and Sexual Dysfunction in Men With Epilepsy and Hypogonadism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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 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.

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. Lab tests, seizure frequency, sexual function and mood will be monitored on a monthly basis.

Conditions

• Seizure Disorder
• Hypogonadism
• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Anastrozole 1mg
DRUG	Placebo Oral Tablet

Timeline

• Start date: 2001-06-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-09-16
• Last updated: 2019-07-17
• Results posted: 2017-08-08

Locations

1 site across 1 country: United States