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Active, not recruitingNCT06851598Updated Feb 28, 2025

Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle for Premature Ejaculation

A Phase 2/3 interventional study of 25 units botox and 50 units Botox in Premature Ejaculation, sponsored by Abdallah Mohamed Abdallah Mohamed Elgendy. Active, not recruiting at 1 site in Egypt. Open to male participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Abdallah Mohamed Abdallah Mohamed Elgendy · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2024, registered Feb 2025).
Phase
Phase 2/3
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
Male
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Study summary

The aim of this work is to assess the efficacy and safety of Botulinum toxin - A injection into ischiocavernosus muscle in treatment of primary premature ejaculation.

Read the detailed description

Premature ejaculation (PE) is among the most common sexual dysfunctions of men (Porst et al., 2007; Waldinger et al., 2004). It affects more than 50% of men in some populations (Irfan et al., 2020). PE has negative impacts on these men's quality of life, as well as their sexual partners (Rosen \& Althof, 2008; Sridharan et al., 2018). The International Society for Sexual Medicine (ISSM) defines PE based on three criteria: the men who have from the first intercourse persistently occurring ejaculation in ≤ 1 min of intercourse (lifelong PE) or significantly reduced ejaculation time (≤ 3 min) later in life (acquired PE), failed to delay ejaculation almost all the time of sexual intercourse, and have developed negative personal and mental conditions (e.g., bother, frustration, distress) and eventually sexual avoidance (Serefoglu et al., 2014). Two types of PE have been widely recognized, ie, lifelong (primary) and acquired (secondary) PE. Lifelong PE is present from the first sexual experience onwards, occurs in almost all attempts at intercourse, and is considered to have a neurobiological etiology. Secondary PE occurs later in life after a period of perceived normal ejaculatory control, and may have a psychological and neurobiological etiology. This type of PE may be triggered by stress or linked to adverse events associated with medications (McCarty E \& Dinsmore W, 2012). Treatment of PE varied from behavioral techniques, selective serotonin reuptake inhibitors and local anesthetics with reported variable outcomes, unsatisfactory for many patients (Hanafy S et al.,2019). New lines have been always evolving trying to address this resistant category of patients such as injection of the glans penis with filler (Abdallah H et al.,2012) and neurectomy of the dorsal nerve of the penis (Liu Q et al.,2019). Ejaculation is a spinal cord reflex, which is constituted by emission and expulsion phases (Giuliano F \& Clement P,2005). During expulsion, rhythmic contractions of the bulbospongiosus and ischiocavernosus muscles propel semen antegrade through the bulbar and penile urethra. Botulinum-A toxin is a selective blocker of acetylcholine release from nerve endings and inhibits neural transmission when injected into muscle (Whelchel DD et al.,2004). The ischiocavernosus muscle (ICM) encompasses a pair of short pinnate muscles attached to the pelvic ring. This muscle originates at the ischial tuberosity and ends at the crus of the penis while covering the surface of the crus (Hsu GL et al.,2004). The concept of inhibiting stereotyped rhythmic contractions of the bulbospongiosus muscle with Botulinum toxin - A injection for the treatment of lifelong premature ejaculation was initially suggested in 2010 (Serefoglu and Silay, 2010).

02

Conditions studied

  • Premature Ejaculation

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03

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's enrollment of 45 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

This is the only study on the registry with Abdallah Mohamed Abdallah Mohamed Elgendy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Patients with primary (lifelong) PE, with Ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration according to The International Society for Sexual Medicine (ISSM) In August 2014.

      _2. Being married for at least 4 months, and in a stable relationship with regular sexual intercourse at least twice per week with a cooperative female partner.

    1. Normal erectile function.
    1. Age 18-65 years.

Exclusion criteria

Exclusion Criteria:

  1. Erectile dysfunction or other Andrological disorders e.g., Cryptorchidism, Peyronie's disease and 3rd degree varicocele. 2. Major psychiatric or psychological illness. 3. Chronic medical disorders that may limit the usage of Botulinum toxin - A such as myasthenia gravis. 4. Men receiving medications that could affect ejaculatory function e.g., Antidepressants and antihypertensive. 5. Age less than 18 or more than 65.

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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Group A

    Drug: 25 units botox

  • Experimental
    Group B

    Drug: 50 units Botox

  • Experimental
    Group C

    Drug: 75 units Botox

Interventions

  • Drug25 units botox

    25 units of botox injection into ischiocavernosus muscle

  • Drug50 units Botox

    50 Units botox injection into ischiocavernosus muscle

  • Drug75 units Botox

    75 units botox injection into ischiocavernosus muscle

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What researchers measure

Primary outcomes

  1. IELT(intravaginal ejaculatory latency time) twice weekly

    With phone stopwatch in seconds twice weekly

    Time frame: 3 Weeks before and 3 weeks after injection

07

Study locations

1 site
  • Faculty of Medicine, Al-Azhar University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Clinical study report

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2024 to primary completion in Feb 2025, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2025
First posted
Feb 28, 2025
StartActual
Jul 1, 2024
Primary completionActual
Feb 1, 2025
CompletionEst.
Mar 1, 2025
Last update
Feb 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06851598
Lead sponsor
Abdallah Mohamed Abdallah Mohamed Elgendy
Responsible party
Abdallah Mohamed Abdallah Mohamed Elgendy (Abdallah Elgendy, Al-Azhar University) — Sponsor-investigator
First posted
Feb 28, 2025
Start date
Jul 1, 2024
Primary completion
Feb 1, 2025
Completion
Mar 1, 2025 (estimated)
Last update
Feb 28, 2025

Study contacts

Abdelraouf Elmohsen, Professor
study chair · Dermatology, Venereology and Andrology Faculty of Medicine, Al-Azhar University
Ahmed Elshahid, Professor
study director · Dermatology, Venereology and Andrology Faculty of Medicine, Al-Azhar University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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