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Clinical Trials in Egypt / NCT06851598
Active, not recruiting Phase 2/3

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

NCT06851598 · tracked via the Priya Life Science Egypt tracker
Sponsor
Abdallah Mohamed Abdallah Mohamed Elgendy
Phase
Phase 2/3
Started
2024-07-01
Last updated
2025-02-28

Condition(s) studied

Premature Ejaculation

Investigational drug(s) / intervention(s)

25 units botox →50 units Botox →75 units Botox →

25 units botox: 25 units of botox injection into ischiocavernosus muscle

50 units Botox: 50 Units botox injection into ischiocavernosus muscle

75 units Botox: 75 units botox injection into ischiocavernosus muscle

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.

Eligibility

Sex
MALE
Min age
16 Years
Max age
65 Years
Healthy volunteers
No
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. * 3\. Normal erectile function. * 4\. Age 18-65 years. 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. \-

Primary outcome measure(s)

  • IELT(intravaginal ejaculatory latency time) twice weekly — 3 Weeks before and 3 weeks after injection
    With phone stopwatch in seconds twice weekly

Trial sites (1)

FacilityCityRegionStatus
Faculty of Medicine, Al-Azhar University Cairo Egypt

Other trials for the same condition

Pelvic Floor Therapies for Lifelong Premature Ejaculation Recruiting
Therapeutic Outcomes of Selective Serotonin Reuptake Inhibitors and Phosphodiesterase-5 Inhibitors Combination Therapy Versus Monotherapy Starting soon
Impact of Depression Severity on Sexual Dysfunction Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06851598 on ClinicalTrials.gov ↗ ← All trials in Egypt