Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
NCT ID: NCT06649539
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
40 participants
INTERVENTIONAL
2024-10-11
2029-10-31
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Primary Cohort
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.
Collagenase Clostridium Histolyticum
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
RestoreX
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.
Sildenafil
Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.
Interventions
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Collagenase Clostridium Histolyticum
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
RestoreX
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.
Sildenafil
Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Prior treatment with CCH injections
* Any contraindications to CCH - as determined by the PI
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Charitable Union for the Research and Education of Peyronie's Disease
OTHER
Responsible Party
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Landon Trost
Principal Investigator, MD
Principal Investigators
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Landon Trost, MD
Role: PRINCIPAL_INVESTIGATOR
Charitable Union for the Research and Education of Peyronie's Disease
Locations
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Male Fertility and Peyronie's Clinic
Orem, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CUREPD120
Identifier Type: -
Identifier Source: org_study_id
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