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

Information source: Beth Israel Deaconess Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seizure Disorder; Hypogonadism; Erectile Dysfunction

Intervention: Arimidex (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Andrew Herzog, M.D., M.Sc., Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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 outcome:

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.

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

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States
Additional Information

Starting date: June 2001
Last updated: May 5, 2008

Page last updated: August 20, 2015

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