Peyronie DiseaseNCT04370652
Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum
An observational study of Peyronie Disease, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peyronie Disease
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
Who may be able to join
- 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°
Who cannot join
- Surgery for Peyronie's disease before
- Anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum (CCH or Xiapex®): Sexual and Psychological Impact and Results From 156 Patients' Questionnaires Data
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.
- Conditions
- Peyronie Disease
- Keywords
- Collagenase Clostridium Histolyticum, Xiapex®, Peyronie's Disease Questionnaire (PDQ), Sexual dysfunction
- Medical subject headings
- Penile Induration, Sexual Dysfunction, Physiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: every 4 weeks for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Jan 2015
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard Fortier, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370652
- Sponsor's protocol ID
- RECHMPL20_0202
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum (CCH or Xiapex®): Sexual and Psychological Impact and Results From 156 Patients' Questionnaires Data
- ClinicalTrials.gov ID
- NCT04370652
- Acronym / sponsor ID
- RECHMPL20_0202
- Conditions
- Peyronie Disease
- Keywords
- Collagenase Clostridium Histolyticum, Xiapex®, Peyronie's Disease Questionnaire (PDQ), Sexual dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 1 May 2020 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
Key inclusion criteria (3 listed)
- 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°
Key exclusion criteria (2 listed)
- Surgery for Peyronie's disease before
- Anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peyronie's Disease Questionnaire (PDQ)
Time frame: every 4 weeks for 2 years
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
1 secondary outcome
Penile curvature angulation
Time frame: every 4 weeks for 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: Undecided. NC
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Platelet-Rich Plasma for Peyronie's Disease
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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.
Edouard Fortier, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peyronie Disease, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 May 2020. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peyronie's Disease Questionnaire (PDQ) (time frame: every 4 weeks for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2020.