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Collagenase

Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response

Phase 4
Waitlist Available
Led By Jed Kaminetsky, MD
Research Sponsored by Manhattan Medical Research Practice, PLLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening up to 24 weeks
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4 additional cycles of treatment.

Eligible Conditions
  • Curved penis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the degree of penile curvature

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single-ArmExperimental Treatment1 Intervention
Xiaflex® 0.58 mg, 2 injections separated by 1 to 3 days, repeated after 6 weeks for up to 4 treatment cycles.

Find a Location

Who is running the clinical trial?

Endo PharmaceuticalsIndustry Sponsor
135 Previous Clinical Trials
33,681 Total Patients Enrolled
Manhattan Medical Research Practice, PLLCLead Sponsor
Jed Kaminetsky, MDPrincipal InvestigatorPrincipal Investigator
2 Previous Clinical Trials
216 Total Patients Enrolled
~3 spots leftby Dec 2025
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