An interventional study of BoNT-A and Placebo injection (normal saline) in Premature (Early) Ejaculation, sponsored by Al Mouwasat Hospital. Completed at 1 site in Saudi Arabia. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Al Mouwasat Hospital · Not applicable, Interventional, and Treatment
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.
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
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 150 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →This is the only study on the registry with Al Mouwasat Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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 -
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 , to botulinum toxin ,mythenia gravis
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: BoNT-A
placebo injection were administered into the bulbospongiosus muscle and the glans penis using the same procedure and volume as the experimental intervention
Drug: Placebo injection (normal saline)
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
injection of equivalent amount of normal saline by same technique and mechanism into the bulbospongiosus muscle and the glans penis
Also known as: sodium chloride
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
Time frame: 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
Time frame: Baseline to 6 months after intervention
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
Time frame: Baseline to 6 months after intervention
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan
Time frame: beginning 3 months following publication and ending 5 years after publication
Access criteria: data will be available to researchers who provide a methodologically sound proposals and will be reviewed by the corresponding author. Data will be shared after de-identification
Data sharing details ↗ · available-upon-request
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Botulinum toxin type A