Peyronie DiseasePhase 4NCT05777031
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
A Phase 4 study testing Collagenase Clostridium Histolyticum (CCH) in people with Peyronie Disease and Sexual Dysfunctions, Psychological, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Peyronie Disease, Sexual Dysfunctions, Psychological, Genital Diseases, Male
- What is being tested?
- Collagenase Clostridium Histolyticum (CCH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Oct 2023to 15 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to provide written informed consent
- Have a diagnosis of PD with evidence of stable disease as determined by the investigator
- Patient must have palpable penile plaque
- Penile curvature deformity of >30° to <90°
- Agree to comply with all study related tests/procedures.
- Prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature
Who cannot join
- Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis.
- Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included.
- Previous history of priapism or penile fracture
- PD characterized by a ventral plaque
- Severe erectile dysfunction as characterized with an IIEF score ≤ 12
- Hour-glass deformity
Show all 10Show fewer
- Unwilling to participate
- Medically unfit for sexual intercourse as deemed by the principal investigator
- Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami - Desai Sethi Urology Institute
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
About this study
Official title: Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease
The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
- Being tested
- Collagenase Clostridium Histolyticum (CCH)
- Medical subject headings
- Penile Induration, Sexual Dysfunctions, Psychological, Genital Diseases, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase Clostridium Histolyticum (CCH)Drug
Also called Xiaflex
Injection of intralesional CCH (0.58mg) to the penile plaque at the point of maximal curvature. Second injection of each cycle will be injected 2-3mm apart from the prior injection.
| Study group | Role | What they receive |
|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) Group | Experimental | There will be 8 total treatments. These will follow the manufacturer protocol of 2 injections 24-72 hours apart (one cycle), followed by a 6-week break. This will total a maximum of 4 cycles. Receives: Drug: Collagenase Clostridium Histolyticum (CCH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Related Adverse Events
To determine number of treatment related adverse events. Safety will be evaluated via the incidence of adverse events as assessed by treating physician
Measured: up to 6 months (post-intervention)
Percent change of penile curvature in degrees.
Treatment efficacy of CCH will be assessed via the percentage of participants achieving degree change in penile curvature from baseline. Degree of curvature will be measured using a goniometer with the aid of injection of vasoactive substance into the penis.
Measured: Baseline up to 6 months
Secondary outcomes (2)
Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
Treatment efficacy will be assessed via the change of participants achieving any decrease in Peyronie's disease Questionnaire (PDQ) sub-domain scoring from baseline. The sub-domains that will be assessed in primary outcome is Psychological and Physical Symptoms and Symptom Bother. PDQ is a validated 15-item questionnaire that assess Psychological and Physical Symptoms, Symptom Bother, and Penile Pain subdomains. The Psychological and Physical Symptoms subdomain is measured from 0 to 24 (most severe symptoms). Symptom Bother subdomain is measured from 0 to 30 (most severe pain).
Measured: Baseline, 6 months.
Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores
IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start2 Oct 2023
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Responsible party
- Principal investigator, Manuel Molina Leyba, University of Miami
- Investigators
- Thomas Masterson, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777031
- Sponsor's protocol ID
- 20221234
- Status last verified
- Jun 2026
- First submitted
- 8 Mar 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease
- ClinicalTrials.gov ID
- NCT05777031
- Acronym / sponsor ID
- 20221234
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) Group | Experimental | Drug: Collagenase Clostridium Histolyticum (CCH)There will be 8 total treatments. These will follow the manufacturer protocol of 2 injections 24-72 hours apart (one cycle), followed by a 6-week break. This will total a maximum of 4 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able to provide written informed consent
- Have a diagnosis of PD with evidence of stable disease as determined by the investigator
- Patient must have palpable penile plaque
- Penile curvature deformity of >30° to <90°
- Agree to comply with all study related tests/procedures.
Key exclusion criteria (10 listed)
- Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis.
- Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included.
- Previous history of priapism or penile fracture
- PD characterized by a ventral plaque
- Severe erectile dysfunction as characterized with an IIEF score ≤ 12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagenase Clostridium Histolyticum (CCH)Also: XiaflexInjection of intralesional CCH (0.58mg) to the penile plaque at the point of maximal curvature. Second injection of each cycle will be injected 2-3mm apart from the prior injection. | Drug | Collagenase Clostridium Histolyticum (CCH) Group |
Primary outcome
Number of Treatment Related Adverse Events
Time frame: up to 6 months (post-intervention)
To determine number of treatment related adverse events. Safety will be evaluated via the incidence of adverse events as assessed by treating physician
Percent change of penile curvature in degrees.
Time frame: Baseline up to 6 months
Treatment efficacy of CCH will be assessed via the percentage of participants achieving degree change in penile curvature from baseline. Degree of curvature will be measured using a goniometer with the aid of injection of vasoactive substance into the penis.
2 secondary outcomes
Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
Time frame: Baseline, 6 months.
Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Peyronie Disease
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
Recruiting
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Peyronie Disease, Erectile Dysfunction
Recruiting
Platelet-Rich Plasma for Peyronie's Disease
Peyronies Disease
Active, not recruitingPhase 4
Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Peyronie Disease
Active, not recruitingPhase 4
Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
Peyronie's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Masterson, MD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagenase Clostridium Histolyticum (CCH) in people with Peyronie Disease and Sexual Dysfunctions, Psychological, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Related Adverse Events (time frame: up to 6 months (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.