Clinical trial NCT00179517: Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
Official title: Comparison of Anastrozole and Testosterone Versus Placebo and Testosterone Treatment of Reproductive and Sexual Dysfunction in Men With Epilepsy and Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seizure Disorder
Hypogonadism
Erectile Dysfunction
Keywords: Seizure
Epilepsy
Testosterone
Hormone
Sexual Dysfunction
Hypogonadism
Men
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-16
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.
timeFrame: 3 month average
Secondary outcomes:
measure: The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo
timeFrame: Assessed for 3 months
measure: Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
timeFrame: Assessed for 3 months
measure: Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
timeFrame: Assessed for 3 months
measure: The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo.
timeFrame: Assessed for 3 months
measure: Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
timeFrame: Assessed for 3 months
measure: Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
timeFrame: Assessed for 3 months
measure: Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P).
timeFrame: Assessed for 3 months
measure: Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
timeFrame: Assessed for 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Andrew Herzog, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herzog AG, Farina EL, Drislane FW, Schomer DL, Smithson SD, Fowler KM, Dworetzky BA, Bromfield EB. A comparison of anastrozole and testosterone versus placebo and testosterone for treatment of sexual dysfunction in men with epilepsy and hypogonadism. Epilepsy Behav. 2010 Feb;17(2):264-71. doi: 10.1016/j.yebeh.2009.12.003. Epub 2010 Jan 21.