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New study tests injections to help men with Drug-Resistant premature ejaculation

NCT ID NCT07236632

Disease control Sponsor: Benha University Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests two injection treatments for men with lifelong premature ejaculation that hasn't improved with standard drugs or therapy. Eighty men will receive either hyaluronic acid into the penis head or botox into a pelvic muscle. Researchers will track changes in ejaculation time, symptom scores, and side effects over one year to see which works better.

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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

22 to 45 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: * Adult male patients aged 22 to 45 years. * Sexually active and in a stable heterosexual relationship. * Circumcised. * Able to understand and comply with study procedures and follow-up visits. * Diagnosed with lifelong drug-resistant premature ejaculation, defined as persistent ejaculation within one minute of penetration despite prior pharmacologic or behavioral therapy. * Normal serum total testosterone, prolactin, and thyroid-stimulating hormone levels. * Willing to provide written informed consent. Exclusion Criteria: * Presence or history of erectile dysfunction or other sexual or ejaculatory disorders such as retrograde ejaculation or acquired premature ejaculation. * History of acute or chronic prostatitis. * Any debilitating medical condition including hepatic failure, renal failure, or uncontrolled diabetes mellitus. * Previous pelvic or spinal surgery. * Prior chemotherapy or radiotherapy. * Use of antipsychotic or neuroactive medications that may affect ejaculation. * History of substance abuse or current drug dependence. * Presence of penile prosthesis, penile deformity, or anatomic abnormalities of the glans or shaft. * Known hypersensitivity or allergy to botulinum toxin or hyaluronic acid preparations. * Any condition that, in the investigator's opinion, may interfere with the safety or evaluation of the study treatment.

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Conditions

The condition(s) this trial relates to.

premature ejaculation

As listed by the trial registrant

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

Premature ejaculation

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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