NCT04370652|Completed
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Sponsor study identifier
observational
156
1 country
1
Study Start
January 1, 2015
Actual (reported)Primary Completion
December 1, 2019
Actual (reported)Study Completion
December 30, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2015
Actual (reported)December 1, 2019
Actual (reported)December 30, 2019
Actual (reported)April 15, 2020
Actual (reported)May 1, 2020
Actual (reported)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
every 4 weeks for 2 years
Penile curvature angulation
every 4 weeks for 2 years
Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
Uhmontpellier
Montpellier, 34295, France
Edouard Fortier, MD
University Hospital, Montpellier
156 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2020
First Posted
May 1, 2020
Study Start
January 1, 2015
Actual (reported)Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Contact the study team to confirm eligibility.
Primary Completion
December 1, 2019
Actual (reported)Study Completion
December 30, 2019
Actual (reported)Last Updated
May 1, 2020
Record last verified: 2020-04
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Source: ClinicalTrials.gov.
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