Treatment of Sexual Dysfunction in Men With Epilepsy With Testosterone and Either Arimidex or Placebo
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Comparison of Arimidex and Testosterone Versus Placebo and Testosterone Treatment of Reproductive and Sexual Dysfunction in Men With Epilepsy and Hypogonadism|
- 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.
- 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.
|Study Start Date:||June 2001|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179517
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Andrew Herzog, M.D., M.Sc.||Beth Israel Deaconess Medical Center|