Official Title: “Comparison of Arimidex and Testosterone Versus Placebo and Testosterone Treatment of Reproductive and Sexual Dysfunction in Men With Epilepsy and Hypogonadism”

The purpose of this study is to determine if treatment using a medication (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. Arimidex, the medication that is currently under study, does not, at this time, have FDA approval for use for this indication.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

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

Intervention(s) in this Clinical Trial

• Drug: Arimidex

Primary Measures

• The specific purpose of this investigation is to determine if sexual function scores increase more with Arimidex and testosterone treatment than with placebo and testosterone treatment.

Secondary Measures

• A greater proportion of men will achieve normalization of sexual scores using Arimidex than placebo.
• Bioactive testosterone levels will increase more with Arimidex than with placebo.
• Estradiol levels will decrease more with Arimidex than with placebo.
• Bioactive testosterone/estradiol ratios will be higher with Arimidex than with placebo.
• Bioactive testosterone/luteinizing hormone ratios will be higher with Arimidex than placebo.
• Estradiol/luteinizing hormone ratios will be lower with Arimidex than placebo.
• Changes in sexual scores will correlate inversely with serum estradiol levels and positively with increases in bioactive testosterone/estradiol ratios and possibly bioactive testosterone levels.
• Changes in seizure frequency will be more favorable with Arimidex than with placebo.
• Changes in energy, mood and anxiety scores will be more favorable with Arimidex than with placebo.

Inclusion Criteria:

• 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 Criteria:

• Subject that has taken hormones, major tranquilizers or antidepressants in the three months prior to entry.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Beth Israel Deaconess Medical Center

Overall Clinical Trial Officials and Contacts

Andrew Herzog, M.D., M.Sc. Principal Investigator Beth Israel Deaconess Medical Center  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00179517

Study ID Number: 2001P-000149

ClinicalTrials.gov Identifier: NCT00179517

Health Authority: United States: Food and Drug Administration