Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a second injection fix penile curvature?

NCT ID NCT05777031

Disease control Sponsor: University of Miami 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a drug called Xiaflex (collagenase clostridium histolyticum) is safe and effective for men with Peyronie's disease who have already tried platelet-rich plasma (PRP) injections. Twelve men with stable penile curvature between 30 and 90 degrees will receive Xiaflex injections into the penile plaque. Researchers will track side effects and measure changes in curvature and symptom bother.

What this could mean

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

Active substance
Collagenase clostridium histolyticum (Xiaflex)
What this could lead to
If it works, this could offer a treatment option for men with Peyronie's disease who previously tried PRP without success.
What could go wrong
This is a very small, early-phase study with only 12 participants, so results may not apply to everyone. Side effects like penile bruising or pain are possible.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

12 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Jan 2027

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

18 to 75 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: 1. Be able to provide written informed consent 2. Have a diagnosis of PD with evidence of stable disease as determined by the investigator 3. Patient must have palpable penile plaque 4. Penile curvature deformity of \>30° to \<90° 5. Agree to comply with all study related tests/procedures. 6. Prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature Exclusion Criteria: 1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis. 2. Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included. 3. Previous history of priapism or penile fracture 4. PD characterized by a ventral plaque 5. Severe erectile dysfunction as characterized with an IIEF score ≤ 12 6. Hour-glass deformity 7. Unwilling to participate 8. Medically unfit for sexual intercourse as deemed by the principal investigator 9. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy. 10. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Genital diseases, male are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

male reproductive system disorder Penile Induration Peyronie disease psychosexual disorder reproductive system disorder Sexual Dysfunctions, Psychological

As listed by the trial registrant

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

Genital diseases, male Peyronie disease Sexual dysfunctions, psychological

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Miami - Desai Sethi Urology Institute

    Miami, Florida, 33136, United States

More trials for these conditions

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