Premature (Early) EjaculationDUAL - PENCT07426640
Dual-Site Botulinum Toxin Type A Injection for Lifelong Premature Ejaculation
A study testing BoNT-A in people with Premature (Early) Ejaculation, run by Al Mouwasat Hospital at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Premature (Early) Ejaculation
- What is being tested?
- BoNT-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2021to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Inclusion Criteria: male participants aged 20 years or older . diagnosis with lifelong premature ejaculation, in a stable heterosexual relationship for at least 6 months prior to enrollment, engaged in vaginal intercourse during the study period, willing and able to provide written informed consent -
Exclusion Criteria: presence of acquired premature ejaculation, history of erectile dysfunction require treatment , current use of medication known to affect ejaculation or sexual function ,previous treatment with botulinum toxin for sexual dysfunction ,history of sever neurological or psychatricor endocrine disorders affection sexual function , active genital infection or penile anatomical abnormalities , hypersensitivity to botulinum toxin ,mythenia gravis
-
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Department of Urology Al Mouwasat Hospital Riyadh
Riyadh, Riyadh Region, 11536
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Trial of Dual-Site Botulinum Toxin Type A Injection Into the Bulbospongiosus Muscle and Glans Penis for Lifelong Premature Ejaculation
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.
Read the detailed description
Lifelong premature ejaculation is a common male sexual disorder characterized by ejaculation that occurs with minimal sexual stimulation and causes personal distress. Although several pharmacological and behavioral treatment options are available, a subset of patients does not achieve satisfactory results or experiences side effects.
Botulinum toxin type A has neuromodulatory properties that may influence ejaculatory reflex pathways. This randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of dual-site botulinum toxin type A injection in men with lifelong premature ejaculation.
Eligible participants were randomly assigned to receive either botulinum toxin type A or placebo injections. Injections were administered into the bulbospongiosus muscle and the glans penis under standardized conditions. Participants were followed for six months after treatment.
The primary outcome measure was intravaginal ejaculatory latency time. Secondary outcomes included patient-reported measures of sexual satisfaction, perceived control over ejaculation, and quality of life. Safety outcomes and adverse events were monitored throughout the study period
- Conditions
- Premature (Early) Ejaculation
- Being tested
- BoNT-A, Placebo injection (normal saline)
- Keywords
- premature ejaculation, Botulinum toxin type A, intravaginal Ejaculatory Latency TIME, Sexual Dysfunction
- Medical subject headings
- Premature Birth, Premature Ejaculation, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoNT-ADrug
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
Placebo injection (normal saline)Drug
Also called sodium chloride
injection of equivalent amount of normal saline by same technique and mechanism into the bulbospongiosus muscle and the glans penis
| Study group | Role | What they receive |
|---|---|---|
| BOTULINUM TOXIN TYPE A | Experimental | Botulinum toxin type A was injected into the bulbospongiosus muscle and glans penis according to a standerdized protocol. this intervention was designed to modulate neuromuscular activity involved in the ejaculatory reflex Receives: Drug: BoNT-A |
| placebo | Placebo comparator | placebo injection were administered into the bulbospongiosus muscle and the glans penis using the same procedure and volume as the experimental intervention Receives: Drug: Placebo injection (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravaginal ejaculatory latency time (IELT )
intravaginal ejaculatory latency time was defined as the time from vaginal penetrationto ejaculation . measured by stopwatch in minutes or seconds
Measured: Baseline to 6 months after intervention
Intravaginal Ejaculatory Latency Time ( IELT)
(IELT) was defined as the time from vaginal penetration to ejaculation, measured in minutes using a stopwatch
Measured: Baseline to 6 months after intervention
Secondary outcomes (1)
sexual satisfaction
sexual satisfaction was assessed using a validated patient-reported questionnaire completed by participants during the study follow up period which reflect quality of life
Measured: Baseline to 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Nov 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature (Early) 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants were randomly assigned to one of two parallel groups to receive either botulinum toxin type A injection or placebo injections and were followed prospectively
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Mouwasat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAITHAM ABDALLA, Al Mouwasat Hospital
- Investigators
- Haitham Abdalla Shello, MD, Principal investigator, AL MOUWASAT HOSPITAL ,RIYADH SAUDI ARABIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426640
- Sponsor's protocol ID
- AMMS-PE-BoNTA-2021
- Acronym
- DUAL - PE
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the article,along with the study protocol and statistical analysis plan,will be made available upon reasonable request to the corresponding author following publication
Publications
Althof SE, Abdo CH, Dean J, Hackett G, McCabe M, McMahon CG, Rosen RC, Sadovsky R, Waldinger M, Becher E, Broderick GA, Buvat J, Goldstein I, El-Meliegy AI, Giuliano F, Hellstrom WJ, Incrocci L, Jannini EA, Park K, Parish S, Porst H, Rowland D, Segraves R, Sharlip I, Simonelli C, Tan HM; International Society for Sexual Medicine. International Society for Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation. J Sex Med. 2010 Sep;7(9):2947-69. doi: 10.1111/j.1743-6109.2010.01975.x.
PubMed 21050394Waldinger MD. Premature ejaculation: definition and drug treatment. Drugs. 2007;67(4):547-68. doi: 10.2165/00003495-200767040-00005.
PubMed 17352514McMahon CG, Althof S, Waldinger MD, Porst H, Dean J, Sharlip I, Adaikan PG, Becher E, Broderick GA, Buvat J, Dabees K, Giraldi A, Giuliano F, Hellstrom WJ, Incrocci L, Laan E, Meuleman E, Perelman MA, Rosen R, Rowland D, Segraves R; International Society for Sexual Medicine Ad Hoc Committee for Definition of Premature Ejaculation. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. BJU Int. 2008 Aug;102(3):338-50. doi: 10.1111/j.1464-410X.2008.07755.x. Epub 2008 May 21.
PubMed 18498422
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Trial of Dual-Site Botulinum Toxin Type A Injection Into the Bulbospongiosus Muscle and Glans Penis for Lifelong Premature Ejaculation
- ClinicalTrials.gov ID
- NCT07426640
- Acronym / sponsor ID
- DUAL - PE / AMMS-PE-BoNTA-2021
- Conditions
- Premature (Early) Ejaculation
- Keywords
- premature ejaculation, Botulinum toxin type A, intravaginal Ejaculatory Latency TIME, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Al Mouwasat HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 23 Feb 2026 (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.
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.
Detailed description
Lifelong premature ejaculation is a common male sexual disorder characterized by ejaculation that occurs with minimal sexual stimulation and causes personal distress. Although several pharmacological and behavioral treatment options are available, a subset of patients does not achieve satisfactory results or experiences side effects.
Botulinum toxin type A has neuromodulatory properties that may influence ejaculatory reflex pathways. This randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of dual-site botulinum toxin type A injection in men with lifelong premature ejaculation.
Eligible participants were randomly assigned to receive either botulinum toxin type A or placebo injections. Injections were administered into the bulbospongiosus muscle and the glans penis under standardized conditions. Participants were followed for six months after treatment.
The primary outcome measure was intravaginal ejaculatory latency time. Secondary outcomes included patient-reported measures of sexual satisfaction, perceived control over ejaculation, and quality of life. Safety outcomes and adverse events were monitored throughout the study period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- participants were randomly assigned to one of two parallel groups to receive either botulinum toxin type A injection or placebo injections and were followed prospectively
| Arm | Type | Receives |
|---|---|---|
| BOTULINUM TOXIN TYPE A | Experimental | Drug: BoNT-ABotulinum toxin type A was injected into the bulbospongiosus muscle and glans penis according to a standerdized protocol. this intervention was designed to modulate neuromuscular activity involved in the ejaculatory reflex |
| placebo | Placebo comparator | Drug: Placebo injection (normal saline)placebo injection were administered into the bulbospongiosus muscle and the glans penis using the same procedure and volume as the experimental intervention |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| BoNT-Aparticipants 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 | BOTULINUM TOXIN TYPE A |
| Placebo injection (normal saline)Also: sodium chlorideinjection of equivalent amount of normal saline by same technique and mechanism into the bulbospongiosus muscle and the glans penis | Drug | placebo |
Primary outcome
intravaginal ejaculatory latency time (IELT )
Time frame: Baseline to 6 months after intervention
intravaginal ejaculatory latency time was defined as the time from vaginal penetrationto ejaculation . measured by stopwatch in minutes or seconds
Intravaginal Ejaculatory Latency Time ( IELT)
Time frame: Baseline to 6 months after intervention
(IELT) was defined as the time from vaginal penetration to ejaculation, measured in minutes using a stopwatch
1 secondary outcome
sexual satisfaction
Time frame: Baseline to 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 21050394Althof SE, Abdo CH, Dean J, Hackett G, McCabe M, McMahon CG, Rosen RC, Sadovsky R, Waldinger M, Becher E, Broderick GA, Buvat J, Goldstein I, El-Meliegy AI, Giuliano F, Hellstrom WJ, Incrocci L, Jannini EA, Park K, Parish S, Porst H, Rowland D, Segraves R, Sharlip I, Simonelli C, Tan HM; International Society for Sexual Medicine. International Society for Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation. J Sex Med. 2010 Sep;7(9):2947-69. doi: 10.1111/j.1743-6109.2010.01975.x.
- Results publication: PubMed 17352514Waldinger MD. Premature ejaculation: definition and drug treatment. Drugs. 2007;67(4):547-68. doi: 10.2165/00003495-200767040-00005.
- Results publication: PubMed 18498422McMahon CG, Althof S, Waldinger MD, Porst H, Dean J, Sharlip I, Adaikan PG, Becher E, Broderick GA, Buvat J, Dabees K, Giraldi A, Giuliano F, Hellstrom WJ, Incrocci L, Laan E, Meuleman E, Perelman MA, Rosen R, Rowland D, Segraves R; International Society for Sexual Medicine Ad Hoc Committee for Definition of Premature Ejaculation. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. BJU Int. 2008 Aug;102(3):338-50. doi: 10.1111/j.1464-410X.2008.07755.x. Epub 2008 May 21.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the article,along with the study protocol and statistical analysis plan,will be made available upon reasonable request to the corresponding author following publication
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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.
Haitham Abdalla Shello, MD principal investigator
AL MOUWASAT HOSPITAL ,RIYADH SAUDI ARABIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BoNT-A in people with Premature (Early) Ejaculation, run by Al Mouwasat Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 17 Mar 2026. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
intravaginal ejaculatory latency time (IELT ) (time frame: Baseline to 6 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07426640, which also lists 3 linked publications.
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 17 Mar 2026.