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New injection shows promise for straightening penile curvature

NCT ID NCT07341529

Disease control Sponsor: Lyx Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding Fibrorestil® injections to standard care (traction therapy and pills) can better reduce penile curvature in men with Peyronie's disease. 38 men with stable curvature between 30 and 90 degrees participated. The main goal was to measure curvature change after 28 weeks, along with safety and quality of life.

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

38 people

The number who actually took part.

Started

Jun 2023

Expected to finish

May 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

18 years and older

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 patients aged 18 years or older * Diagnosis of Peyronie's disease with stable symptoms for at least 3 months * Penile curvature between 30 and 90 degrees, assessed by standardized self-photography or Kelami test * Presence of a palpable penile plaque consistent with Peyronie's disease * No prior surgical treatment for Peyronie's disease * Willingness and ability to comply with study procedures, including use of penile traction therapy and completion of questionnaires * Ability to provide written informed consent Exclusion Criteria: * Prior surgical treatment for Peyronie's disease * Known hypersensitivity or allergy to hyaluronic acid or any component of the investigational medical device * Active oncological disease or oncological treatment within the previous 6 months * Systemic immunosuppression * Severe hepatic or renal disease * Medical conditions affecting wound healing or tissue repair (e.g., scleroderma, systemic lupus erythematosus, dermatomyositis) * Active infection or infected scar tissue in the treatment area * Use of other treatments for Peyronie's disease during the study period, including surgery * Any medical condition that, in the investigator's judgment, could increase risk to the participant or interfere with study participation or outcome assessment

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Conditions

The condition(s) this trial relates to.

Penile Induration Peyronie disease

As listed by the trial registrant

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

Peyronie disease

Contacts and locations

Locations

  • Hospital Universitario La Paz (HULP)

    Madrid, Madrid, 28046, Spain

  • Lyx Institute of Urology

    Madrid, Madrid, 28006, Spain

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