Phase 2
N=40
Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
Seizure Disorder · Hypogonadism · Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00179517 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. — 3.7; 2.5; 2.4; 1.5 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anastrozole 1mg (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. |
3.7; 2.5; 2.4; 1.5; 11.1; 4.7 | — |
| SECONDARY The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo |
13; 9; 5; 10 | — |
| SECONDARY Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P). |
150.9; 161.7 | — |
| SECONDARY Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P). |
-14.6; 8.6 | — |
| SECONDARY The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo. |
145.47; 12.78 | — |
| SECONDARY Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P). |
450.24; 482.65 | — |
| SECONDARY Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P). |
9.31; 53.80 | — |
| SECONDARY Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P). |
-2.0; -2.9 | — |
| SECONDARY Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P). |
-5.3; -6.4; 4.6; 4.8; -6.0; -4.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00179517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.