Peyronie DiseasePhase 4NCT06649539

Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease

A Phase 4 study testing Collagenase Clostridium Histolyticum, RestoreX and Sildenafil in people with Peyronie Disease, run by Charitable Union for the Research and Education of Peyronie's Disease at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peyronie Disease
What is being tested?: Collagenase Clostridium Histolyticum, RestoreX and Sildenafil
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 11 Oct 2024to Oct 2029
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men with Peyronie's Disease
Older than 18 years old
Curvature ≥30 degrees
Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors
The patient exhibits a palpable plaque consistent with Peyronie's Disease
For partners, the only inclusion criteria is being willing to complete a questionnaire

Who cannot join

Prior surgical treatment on the penis (other than circumcision)
Prior treatment with CCH injections
Any contraindications to CCH - as determined by the PI

Trial locations and contacts

1 site in 1 country.

United States1 site

Male Fertility and Peyronie's Clinic
Orem, Utah, 84057

Other trials in United States

About this study

Official title: Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease

The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data.

Participants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2.

The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.

Read the detailed description

The current study would prospectively follow 40 men through the following treatment protocol:

Men would receive 4 series of CCH injections according to the protocol below, which represents a modified version of our most recently published technique.13
Medication administered on back-to-back days
Total of 0.9 mg administered with each series, diluted to 0.8 mL
Mild in-office modeling performed on treatment day 2 of each series
Wraps performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising
Sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.
Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final series.
Note that men may stop sooner if they are satisfied before completing the 4 series.
If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol.
This would be performed 9-12 months after the 4th series of injections.
The technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial.
The men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total.

At the time of initial enrollment, partners of study participants will be invited to enroll in the study and will be administered non-validated questionnaires designed to assess the partner's overall support for the ongoing treatment protocol.

Assessments and study questionnaires will be administered at baseline, with the 1st injection of each series, 6 weeks after completing the 4th series of CCH injections, and 1 year after completion of the final series of CCH injections.

Conditions: Peyronie Disease
Being tested: Collagenase Clostridium Histolyticum, RestoreX, Sildenafil
Keywords: collagenase clostridium histolyticum, curvature, Restorex, Xiaflex, traction, salvage
Medical subject headings: Penile Induration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Collagenase Clostridium HistolyticumDrug
Also called Xiaflex, CCH
4 Series given to each participant, 6 weeks apart. Medication administered on back-to-back days. If failing to achieve an adequate response, men may receive up to 2 additional series 9-12 months after the 4th series.
Total of 0.9 mg administered with each series, diluted to 0.8 mL
RestoreXDevice
Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final CCH series.
SildenafilDrug
Also called Viagra
Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.

Study groups in NCT06649539
Study group	Role	What they receive
Primary Cohort	Experimental	Men would receive 4 series of CCH injections: * Administered on back-to-back days * 0.9 mg administered with each series, diluted to 0.8 mL * Mild in-office modeling performed on treatment day 2 of each series * Wraps applied 2-4 full-time and 2-4 part-time days * Sildenafil 25 mg nightly and Restorex beginning treatment day 2 (sildenafil) or 3 (Restorex - 30 min/day) until 6 weeks after final injection of the final series. Note that men may stop sooner if they are satisfied before completing the 4 series. If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol. * Performed 9-12 months after the 4th series of injections. * The technique would incorporate more aggressive, in-office modeling. * Men would receive up to two additional series per this protocol. Receives: Drug: Collagenase Clostridium Histolyticum; Device: RestoreX; Drug: Sildenafil

What is being measured

The primary outcome is the main question the study is designed to answer.

Penile Curvature
Compare penile curvature between baseline and post-treatment in men 1 year after completing the final injection series. A goniometer (protractor) will be used to measure from the penile angulation during a full erection in two planes (dorsal/ventral and lateral). Measurements will be in degrees.
Measured: 1 year
Penile Length
Compare penile length between baseline and post-treatment in men 1 year after completing the final injection series. Measurements will be performed using a ruler, with measurements obtained from the pubic symphysis to the corona of the glans penis (measured in cm).
Measured: 1 year

Secondary outcomes (9)

Penile curvature compared to more aggressive technique
Compare curvature outcomes to our historical series of men treated up-front with the more aggressive technique. This will be done using a goniometer (protractor) with a full erection and measured in two planes (dorsal/ventral and lateral). The curvature will be measured using degrees.
Measured: 1 year
Penile curvature compared to our current salvage approach for CCH
Compare curvature changes to those in our ongoing randomized, controlled trial (NCT05108558) evaluating the salvage approach in men who previously failed 6-8 CCH injections. This will be done using a goniometer (protractor) with a full erection and measured in two planes (dorsal/ventral and lateral). The curvature will be measured using degrees.
Measured: 1 year
Adverse Events
Report subjectively noted adverse events (AE) at 1 year following the final injection series. Patients will be able to write-in specific adverse events, and absolute occurrences of each of the written responses will be summed and reported.
Measured: 1 year
Partner Support
Evaluate partner support as a predictor of whether the patient continues with treatment. Support will be assessed using a non-validated question, "How supportive are you of your partner's decision to undergo Xiaflex treatments?" This will be measured using the selectable options: Very Supportive, Somewhat Supportive, Neutral, Somewhat Unsupportive, and Very Unsupportive.
Measured: 1 year
Compliance with Therapy - Penile Curvature
Evaluate compliance with therapy as a predictor of penile curvature improvements during the study. A daily diary will be maintained by the patient to track actual device utilization. Patients will record how many minutes that they used the device daily. This information will be used to try to correlate penile curvature outcomes with actual device utilization.
Measured: 1 year
Satisfaction with therapy
Report patient-outcome measures related to satisfaction with therapy. This measure will be evaluated using a non-standardized question, "How would you rate your overall satisfaction with Xiaflex?" Patients will be able to select from the following responses: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Very Dissatisfied.
Measured: 1 year
Penile length compared to more aggressive technique
Compare penile length changes to our historical series of men treated up-front with the more aggressive technique. Measurements will be performed using a ruler, with measurements obtained from the pubic symphysis to the corona of the glans penis (measured in cm).
Measured: 1 year
Penile length compared to our current salvage approach for CCH
Compare penile length changes to our ongoing randomized, controlled trial (NCT05108558) evaluating the salvage approach in men who previously failed 6-8 CCH injections. Measurements will be performed using a ruler, with measurements obtained from the pubic symphysis to the corona of the glans penis (measured in cm).
Measured: 1 year
Compliance with Therapy - Penile Length
Evaluate compliance with therapy as a predictor of penile length changes during the study. A daily diary will be maintained by the patient to track actual device utilization. Patients will record how many minutes that they used the device daily. This information will be used to try to correlate penile length outcomes with actual device utilization.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 2024Oct 2029

First posted18 Oct 2024
Study start11 Oct 2024
Primary completionOct 2029 (estimated)
Study completionOct 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
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
Model description: prospective, single-blinded clinical trial
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06649539
Sponsor's protocol ID: CUREPD120
Status last verified: Aug 2026
First submitted: 12 Oct 2024
Last updated: 26 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Nguyen HMT, Anaissie J, DeLay KJ, Yafi FA, Sikka SC, Hellstrom WJG. Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie's Disease. J Sex Med. 2017 Oct;14(10):1220-1225. doi: 10.1016/j.jsxm.2017.08.008. Epub 2017 Sep 2.
PubMed 28874331
Larson H, Warner J, Savage J, Kohler T, Ziegelmann M, Trost L. Changes in Point of Maximal Curvature During Collagenase Clostridium Histolyticum Injections for Peyronie's Disease. Urology. 2024 Feb;184:122-127. doi: 10.1016/j.urology.2023.11.024. Epub 2023 Dec 6.
PubMed 38061610
Gelbard M, Lipshultz LI, Tursi J, Smith T, Kaufman G, Levine LA. Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in patients with Peyronie disease. J Urol. 2012 Jun;187(6):2268-74. doi: 10.1016/j.juro.2012.01.032. Epub 2012 Apr 13.
PubMed 22503048
Alom M, Sharma KL, Toussi A, Kohler T, Trost L. Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease. J Sex Med. 2019 Jun;16(6):891-900. doi: 10.1016/j.jsxm.2019.03.007. Epub 2019 Apr 5.
PubMed 30956106
Ziegelmann MJ, Viers BR, Montgomery BD, Westerman ME, Savage JB, Trost LW. Self-reported Clinical Meaningfulness Early in the Treatment Course Predicts Objective Outcomes in Men Undergoing Collagenase Clostridium histolyticum Injections for Peyronie Disease. Urology. 2017 Aug;106:107-112. doi: 10.1016/j.urology.2017.04.045. Epub 2017 May 5.
PubMed 28483591
Ziegelmann MJ, Viers BR, McAlvany KL, Bailey GC, Savage JB, Trost LW. Restoration of Penile Function and Patient Satisfaction with Intralesional Collagenase Clostridium Histolyticum Injection for Peyronie's Disease. J Urol. 2016 Apr;195(4 Pt 1):1051-6. doi: 10.1016/j.juro.2015.10.065. Epub 2015 Oct 23.
PubMed 26476353
Alom M, Meng Y, Sharma KL, Savage J, Kohler T, Trost L. Safety and Efficacy of Collagenase Clostridium Histolyticum in Peyronie's Disease Men With Ventral Curvatures. Urology. 2019 Jul;129:119-125. doi: 10.1016/j.urology.2019.01.055. Epub 2019 Mar 22.
PubMed 30910455

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peyronie Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease
ClinicalTrials.gov ID: NCT06649539
Acronym / sponsor ID: CUREPD120
Conditions: Peyronie Disease
Keywords: collagenase clostridium histolyticum, curvature, Restorex, Xiaflex, traction, salvage
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: Charitable Union for the Research and Education of Peyronie's DiseaseUniversity, hospital or other
Collaborators: Endo USA Inc., a Keenova Therapeutics Company
Study start: 11 Oct 2024 (actual)
Primary completion: Oct 2029 (estimated)
Study completion: Oct 2029 (estimated)
First posted: 18 Oct 2024 (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 sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.

Detailed description

The current study would prospectively follow 40 men through the following treatment protocol:

Men would receive 4 series of CCH injections according to the protocol below, which represents a modified version of our most recently published technique.13
Medication administered on back-to-back days
Total of 0.9 mg administered with each series, diluted to 0.8 mL
Mild in-office modeling performed on treatment day 2 of each series
Wraps performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising
Sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.
Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final series.
Note that men may stop sooner if they are satisfied before completing the 4 series.
If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol.
This would be performed 9-12 months after the 4th series of injections.
The technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial.
The men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: prospective, single-blinded clinical trial

Arm	Type	Receives
Primary Cohort	Experimental	Drug: Collagenase Clostridium Histolyticum, Device: RestoreX, Drug: SildenafilMen would receive 4 series of CCH injections: * Administered on back-to-back days * 0.9 mg administered with each series, diluted to 0.8 mL * Mild in-office modeling performed on treatment day 2 of each series * Wraps applied 2-4 full-time and 2-4 part-time days * Sildenafil 25 mg nightly and Restorex beginning treatment day 2 (sildenafil) or 3 (Restorex - 30 min/day) until 6 weeks after final injection of the final series. Note that men may stop sooner if they are satisfied before completing the 4 series. If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol. * Performed 9-12 months after the 4th series of injections. * The technique would incorporate more aggressive, in-office modeling. * Men would receive up to two additional series per this protocol.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Men with Peyronie's Disease
Older than 18 years old
Curvature ≥30 degrees
Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors
The patient exhibits a palpable plaque consistent with Peyronie's Disease

Key exclusion criteria (3 listed)

Prior surgical treatment on the penis (other than circumcision)
Prior treatment with CCH injections
Any contraindications to CCH - as determined by the PI

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 HistolyticumAlso: Xiaflex, CCH4 Series given to each participant, 6 weeks apart. Medication administered on back-to-back days. If failing to achieve an adequate response, men may receive up to 2 additional series 9-12 months after the 4th series. Total of 0.9 mg administered with each series, diluted to 0.8 mL	Drug	Primary Cohort
RestoreXRestorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final CCH series.	Device	Primary Cohort
SildenafilAlso: ViagraMen will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.	Drug	Primary Cohort

Primary outcome

Penile Curvature
Time frame: 1 year
Compare penile curvature between baseline and post-treatment in men 1 year after completing the final injection series. A goniometer (protractor) will be used to measure from the penile angulation during a full erection in two planes (dorsal/ventral and lateral). Measurements will be in degrees.
Penile Length
Time frame: 1 year
Compare penile length between baseline and post-treatment in men 1 year after completing the final injection series. Measurements will be performed using a ruler, with measurements obtained from the pubic symphysis to the corona of the glans penis (measured in cm).

9 secondary outcomes

Penile curvature compared to more aggressive technique
Time frame: 1 year
Penile curvature compared to our current salvage approach for CCH
Time frame: 1 year
Adverse Events
Time frame: 1 year
Partner Support
Time frame: 1 year
Compliance with Therapy - Penile Curvature
Time frame: 1 year
Satisfaction with therapy
Time frame: 1 year
Penile length compared to more aggressive technique
Time frame: 1 year
Penile length compared to our current salvage approach for CCH
Time frame: 1 year
Compliance with Therapy - Penile Length
Time frame: 1 year

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 26 Aug 2026.
Background: PubMed 28874331Nguyen HMT, Anaissie J, DeLay KJ, Yafi FA, Sikka SC, Hellstrom WJG. Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie's Disease. J Sex Med. 2017 Oct;14(10):1220-1225. doi: 10.1016/j.jsxm.2017.08.008. Epub 2017 Sep 2.
Background: PubMed 38061610Larson H, Warner J, Savage J, Kohler T, Ziegelmann M, Trost L. Changes in Point of Maximal Curvature During Collagenase Clostridium Histolyticum Injections for Peyronie's Disease. Urology. 2024 Feb;184:122-127. doi: 10.1016/j.urology.2023.11.024. Epub 2023 Dec 6.
Background: PubMed 22503048Gelbard M, Lipshultz LI, Tursi J, Smith T, Kaufman G, Levine LA. Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in patients with Peyronie disease. J Urol. 2012 Jun;187(6):2268-74. doi: 10.1016/j.juro.2012.01.032. Epub 2012 Apr 13.
Background: PubMed 30956106Alom M, Sharma KL, Toussi A, Kohler T, Trost L. Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease. J Sex Med. 2019 Jun;16(6):891-900. doi: 10.1016/j.jsxm.2019.03.007. Epub 2019 Apr 5.
Background: PubMed 28483591Ziegelmann MJ, Viers BR, Montgomery BD, Westerman ME, Savage JB, Trost LW. Self-reported Clinical Meaningfulness Early in the Treatment Course Predicts Objective Outcomes in Men Undergoing Collagenase Clostridium histolyticum Injections for Peyronie Disease. Urology. 2017 Aug;106:107-112. doi: 10.1016/j.urology.2017.04.045. Epub 2017 May 5.
Background: PubMed 26476353Ziegelmann MJ, Viers BR, McAlvany KL, Bailey GC, Savage JB, Trost LW. Restoration of Penile Function and Patient Satisfaction with Intralesional Collagenase Clostridium Histolyticum Injection for Peyronie's Disease. J Urol. 2016 Apr;195(4 Pt 1):1051-6. doi: 10.1016/j.juro.2015.10.065. Epub 2015 Oct 23.
Background: PubMed 30910455Alom M, Meng Y, Sharma KL, Savage J, Kohler T, Trost L. Safety and Efficacy of Collagenase Clostridium Histolyticum in Peyronie's Disease Men With Ventral Curvatures. Urology. 2019 Jul;129:119-125. doi: 10.1016/j.urology.2019.01.055. Epub 2019 Mar 22.
Individual participant dataSharing planned: No

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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.

Landon Trost, MD principal investigator

Charitable Union for the Research and Education of Peyronie's Disease

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Penile Curvature (time frame: 1 year). 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?

On the ClinicalTrials.gov record for NCT06649539, which also lists 7 linked publications.

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 26 Aug 2026.