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Botulinum Toxin for Erectile Dysfunction

NCT03102762 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-01-07

Study results available
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Summary

To evaluate the safety and efficacy of intra-cavernosal Botulinum toxin injection as an alternative line of treatment in patients with erectile dysfunction - not responding to oral PDE5i - through cavernosal smooth muscle relaxation.

Conditions

Interventions

DRUG

Botulinum Toxin Type A

Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment.

DRUG

Normal saline

The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Islam M Fathy, MD · Cairo University

  • Abdelrahman A Hassan, Msc · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-03
Primary Completion
2019-01-10
Completion
2019-01-10
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102762 on ClinicalTrials.gov