Premature EjaculationPhase 2/3NCT06851598
Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle for Premature Ejaculation
A Phase 2/3 study testing 25 units botox, 50 units Botox and 75 units Botox in people with Premature Ejaculation, run by Abdallah Mohamed Abdallah Mohamed Elgendy at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 16 to 65 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- 25 units botox, 50 units Botox and 75 units Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Mar 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle in Treatment of Premature Ejaculation
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).
- Conditions
- Premature Ejaculation
- Being tested
- 25 units botox, 50 units Botox, 75 units Botox
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 units botoxDrug
25 units of botox injection into ischiocavernosus muscle
50 units BotoxDrug
50 Units botox injection into ischiocavernosus muscle
75 units BotoxDrug
75 units botox injection into ischiocavernosus muscle
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: 25 units botox |
| Group B | Experimental | Not described Receives: Drug: 50 units Botox |
| Group C | Experimental | Not described Receives: Drug: 75 units Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
IELT(intravaginal ejaculatory latency time) twice weekly
With phone stopwatch in seconds twice weekly
Measured: 3 Weeks before and 3 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Jul 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdallah Mohamed Abdallah Mohamed Elgendy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdallah Mohamed Abdallah Mohamed Elgendy, Al-Azhar University
- Investigators
- Abdelraouf Elmohsen, Professor, Study chair, Dermatology, Venereology and Andrology Faculty of Medicine, Al-Azhar UniversityAhmed Elshahid, Professor, Study director, Dermatology, Venereology and Andrology Faculty of Medicine, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851598
- Sponsor's protocol ID
- Botox in premature ejaculation
- Status last verified
- Jan 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle in Treatment of Premature Ejaculation
- ClinicalTrials.gov ID
- NCT06851598
- Acronym / sponsor ID
- Botox in premature ejaculation
- Conditions
- Premature Ejaculation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Abdallah Mohamed Abdallah Mohamed ElgendyUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: 25 units botox |
| Group B | Experimental | Drug: 50 units Botox |
| Group C | Experimental | Drug: 75 units Botox |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25 units botox25 units of botox injection into ischiocavernosus muscle | Drug | Group A |
| 50 units Botox50 Units botox injection into ischiocavernosus muscle | Drug | Group B |
| 75 units Botox75 units botox injection into ischiocavernosus muscle | Drug | Group C |
Primary outcome
IELT(intravaginal ejaculatory latency time) twice weekly
Time frame: 3 Weeks before and 3 weeks after injection
With phone stopwatch in seconds twice weekly
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Yes
Related trials for Premature Ejaculation
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Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
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Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 25 units botox, 50 units Botox and 75 units Botox in people with Premature Ejaculation, run by Abdallah Mohamed Abdallah Mohamed Elgendy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IELT(intravaginal ejaculatory latency time) twice weekly (time frame: 3 Weeks before and 3 weeks after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.