Status:
UNKNOWN
Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response
Lead Sponsor:
Manhattan Medical Research Practice, PLLC
Collaborating Sponsors:
Endo Pharmaceuticals
Conditions:
Peyronie's Disease
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4 additional cycles of treatment.
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent to participate in the study.
- Male aged ≥18 years old at screening.
- Previously received Xiaflex® treatment and had a partial or complete response.
- Partial response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a penile curvature of ≥ 15 degrees and \< 90 degrees.
- Complete response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a penile curvature of \< 15 degrees.
- Has a diagnosis of Peyronie's disease with a penile curvature of ≥ 30 and ≤ 90 degrees at the screening visit.
- Has a penile curvature of at ≥ 30 degrees in the dorsal, lateral, or dorsal/lateral plane at the screening visit. It must be possible to delineate the single plane of maximal curvature for evaluation during the study.
- Able and willing to comply with restrictions where intercourse or any other sexual activity is prohibited during each treatment cycle and for at least 2 weeks after each injection cycle.
- Able and willing to perform home modeling sessions between injection cycles.
- Is in good health based on medical history evaluation and in the judgment of the principal investigator.
Exclusion
- Has a penile curvature of \< 30 degrees or \> 90 degrees at the screening visit.
- Previous allergic reaction to XIAFLEX®.
- Has any of the following conditions:
- Chordee in the presence or absence of hypospadias
- Thrombosis of the dorsal penile artery and or vein
- Infiltration by a benign or malignant mass resulting in penile curvature
- Infiltration by an infectious agent, such as lymphogranuloma venereum
- Ventral curvature from any cause
- Presence of an active sexually transmitted disease
- Known active hepatitis B or C
- Known human immune deficiency virus (HIV)
- Has previously undergone surgery for Peyronie's disease.
- Has an erection which, in the opinion of the investigator, is insufficient to accurately measure the subject's penile deformity after administration of the prostaglandin E1 (PGE1), Trimix®, or similar erection inducing agent.
- Has a calcified plaque that, in the opinion of the investigator, would prevent proper administration of the study medication.
- Has an isolated hourglass deformity of the penis.
- Has a plaque causing a curvature of the penis located proximal to the base of the penis where injection of local anesthetic would interfere with the injection of Xiaflex®.
- Has received intralesional or injection therapy for Peyronie's disease including interferon, verapamil, or Xiaflex® \< 6 months prior to screening.
- Has used antiplatelet or anti-coagulants (e.g. coumadin, Plavix®, Eliquis®, Effient®) within 7 days prior to each Xiaflex® injection. Daily aspirin of 81 mg is acceptable.
- Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie's disease within the 6 months prior to screening or plans to have ESWT at any time during the study.
- Has uncontrolled hypertension as determined by the investigator.
- Has a recent history of stroke, bleeding, or other significant medical condition which, in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
- Has a planned surgical procedure during anticipated study participation.
- Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits.
- Has received investigational drug or treatment within 30 days of the first dose Xiaflex®.
Key Trial Info
Start Date :
October 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03767452
Start Date
October 4 2018
End Date
February 1 2020
Last Update
December 7 2018
Active Locations (1)
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1
Manhattan Medical Research Practice, PLLC
New York, New York, United States, 10016