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Botox shots to the penis may help men last longer in bed

NCT ID NCT07426640

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether injecting Botox into the penis and a nearby pelvic muscle can help men with lifelong premature ejaculation last longer during sex. 150 men were randomly assigned to receive either Botox or a placebo injection. The researchers measured ejaculation time and sexual satisfaction over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
botulinum toxin type A (Botox)
What this could lead to
If it works, this could offer a new treatment option for men with lifelong premature ejaculation who do not respond to standard therapies.
What could go wrong
This is a small, completed trial with 150 participants. The results may not apply to all men, and there are risks like injection site pain or temporary muscle weakness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

150 people

The number who actually took part.

Started

Nov 2021

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 50 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \-

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Department of Urology Al Mouwasat Hospital Riyadh

    Riyadh, Riyadh Region, 11536, Saudi Arabia

More trials for these conditions

Other studies related to the condition(s) this trial covers.