CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Botulinum Toxin Type A +1 moredrug
Likely dose
Botulinum Toxin Type A 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02584686
NCT02584686Phase 1Completed
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Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction Not Responding to Oral and Intracavernous Therapy

Cairo University·interventional·Posted Oct 23, 2015·Updated Jan 16, 2017

In Brief

A Phase 1 clinical trial evaluating Botulinum Toxin Type A and Normal Saline for Vasculogenic Erectile Dysfunction. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Evidence has been arising that Botulinum toxin injections can relax smooth muscles fibers in the treatment of obesity and hyperactive bladder. Would a similar effect on cavernosal smooth muscles help in the treatment of resistant erectile dysfunction not responding to medical and injection therapy, thus avoiding surgical treatment options. The treatment group will be injected intracavernously with 50 units of BTX-A. The control group, 12 patients, will be injected with a normal saline injection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVasculogenic Erectile Dysfunction
CountriesEgypt
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 23, 2015
Enrollment StartOct 1, 2015
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.7 years ago

Interventions

Botulinum Toxin Type Adrug

The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A.

Normal Salinedrug

The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection.