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

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Erectile Dysfunction; Seizure Disorder; Hypogonadism

Treatments: Drug: Placebo Oral Tablet; Drug: Anastrozole 1mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00179517

IRUSANAS0004

2001P000149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

depotestosterone plus anastrozole (T-A)

Experimental group

Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes an oral tablet of anastrozole 1 mg daily for the duration of the study. This group is referred to as the depotestosterone plus anastrozole (T-A) group.

Treatment:

Drug: Anastrozole 1mg

depotestosterone plus placebo (T-P)

Placebo Comparator group

Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo oral tablet daily for the duration of the study. This group is referred to as the depotestosterone plus placebo (T-P) group.

Treatment:

Drug: Placebo Oral Tablet