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CompletedNCT04370652Updated May 1, 2020

Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum

An observational study in Peyronie Disease, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-01.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
156
Ages
18 Years and older
Sex
All
01

Study summary

Peyronie's disease is the appearance of a fibrosis plaque on the albuginea of the corpora cavernosa, which produces mechanical traction at the time of erection, inducing a deformation/curvature of the erect penis. The physiopathology is largely unknown.

There is a significant sexual and psychological impact on patients. Historically, the only possible treatment was surgical. The only drug treatment that was FDA approved for this disease was Collagenase from Clostridium Histolyticum marketed under the name Xiapex® until 31/12/2019 by Sobi laboratory. Marketing was stopped on that date for economic reasons and restricted to the US market only.

The investigators propose a retrospective evaluation of the largest French monocentric series of this treatment from the perspective of the sexual and psychological evaluation of patients.

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Conditions studied

  • Peyronie Disease

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Keywords

  • Collagenase Clostridium Histolyticum
  • Xiapex®
  • Peyronie's Disease Questionnaire (PDQ)
  • Sexual dysfunction
03

In context

Penile Induration

45 studies on the registry are indexed under Penile Induration; 10 are open to participants now.

Browse Penile Induration studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution

Inclusion criteria

  • Age ≥ 18 years old
  • Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
  • Angle of penis deformation ≥ 30°

Exclusion criteria

Exclusion criteria:

  • Surgery for Peyronie's disease before
  • Anticoagulation
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
156 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Peyronie's Disease Questionnaire (PDQ)

    Peyronie's Disease Questionnaire (PDQ) : Change in baseline Peyronie's Disease Questionnaire Score each 4 weeks, i.e. before each new injection ; for up 2 years

    Time frame: every 4 weeks for 2 years

Secondary outcomes

  1. Penile curvature angulation

    Penile curvature angulation : Change in baseline penile curvature angulation each 4 weeks, i.e. before each new injection ; for up 2 years

    Time frame: every 4 weeks for 2 years

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04370652
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
May 1, 2020
Start date
Jan 1, 2015
Primary completion
Dec 1, 2019
Completion
Dec 30, 2019
Last update
May 1, 2020

Study contacts

Edouard Fortier, MD
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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