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
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