MedTrace Logo

Dual-Site Botulinum Toxin Type A Injection for Lifelong Premature Ejaculation

NCT07426640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-17

No results posted yet for this study

Summary

Premature ejaculation is a common sexual condition that can cause distress for men and their partners. Different treatments are available, but some men do not respond well to standard therapies.

This study was designed to evaluate whether injecting botulinum toxin type A into two areas of the penis and surrounding muscles can help delay ejaculation in men with lifelong premature ejaculation. Participants were randomly assigned to receive either botulinum toxin injections or placebo injections.

The study evaluated ejaculation time, sexual satisfaction, and quality of life over a follow-up period of six months. Safety and possible side effects were also monitored during the study.

Conditions

  • Premature (Early) Ejaculation

Interventions

DRUG

BoNT-A

participants were randomly assigned to one of two parallel groups to receive either Botulinum toxin type A injection or placebo injections( normal saline ) and were followed prospectively also the dual site injection is new

DRUG

Placebo injection (normal saline)

injection of equivalent amount of normal saline by same technique and mechanism into the bulbospongiosus muscle and the glans penis

Sponsors & Collaborators

  • Al Mouwasat Hospital

    lead OTHER

Principal Investigators

  • Haitham Abdalla Shello, MD · AL MOUWASAT HOSPITAL ,RIYADH SAUDI ARABIA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Saudi Arabia

Study Locations

More Related Trials

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 NCT07426640 on ClinicalTrials.gov