CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Anastrozole 1mg +1 moredrug
Likely dose
Anastrozole 1 mgAI-extracted
Key inclusion· 5
  • ✓Male aged 18–50 years
  • ✓Localization-related epilepsy with complex partial and/or secondary generalized seizures
  • ✓Hypogonadism: abnormally low bioactive testosterone and abnormally low sexual/reproductive function scores
  • ✓Normal urogenital and rectal/prostate exam within the prior year
Key exclusion· 1
  • ✕Use of hormones, major tranquilizers, or antidepressants in the prior 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00179517
NCT00179517Phase 2Completed
CompareCT.gov

Comparison of Anastrozole and Testosterone Versus Placebo and Testosterone Treatment of Reproductive and Sexual Dysfunction in Men With Epilepsy and Hypogonadism

Beth Israel Deaconess Medical Center·interventional·Posted Sep 16, 2005·Updated Jul 17, 2019

In Brief

A Phase 2 clinical trial evaluating Anastrozole 1mg and Placebo Oral Tablet for Seizure Disorder and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeizure Disorder, Hypogonadism, Erectile Dysfunction
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJun 1, 2001
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.8 years ago

Interventions

Anastrozole 1mgdrug

Placebo Oral Tabletdrug