Exploration of treatment effectiveness for Peyronie's disease in a real-world study
The initiation of a non-interventional investigation (NCT05873595) focusing on real-life data analysis to evaluate the effectiveness of available treatments for individuals diagnosed with Peyronie's disease has enrolled its first patient, as reported by Endo Pharmaceuticals, the sponsor of the study.1
Dr. Mohit Khera asserted, "Given that Peyronie's disease does not pose a significant threat to one's life and due to the stigma surrounding the condition, many individuals who suffer from Peyronie's may refrain from seeking medical attention, resulting in an inadequate amount of data on the subject."
The formal name assigned to this trial is "Validation of Treatment Effectiveness in Peyronie's Disease through Comprehensive Real-world Evidence" (CURVE-PD). It is an observational study categorized as a patient registry, with an intended enrollment of 1000 Peyronie's disease patients who have initiated therapy no more than two weeks prior to enrollment or at any point thereafter.
Accumulation of patients will occur at 15 different locations, with a follow-up period lasting for up to one year. The study's researchers will gather data from patients, as well as from their healthcare providers and partners.
The official ClinicalTrials.gov website for the CURVE-PD trial outlines the primary outcome measures as follows:
- Alteration in Peyronie's Disease Questionnaire (PDQ) score from the initial assessment (Time frame: Up to 12 months)
- Modifications in International Index of Erectile Function (IIEF) score from baseline (Time frame: Up to 12 months)
- Distinctions in Patient Health Questionnaire-9 (PHQ-9) score from the initial assessment (Time frame: Up to 12 months)
- Changes in Beck Anxiety Inventory (BAI) Scale score from baseline (Time frame: Up to 12 months)
- Participant Satisfaction Questionnaire (Time frame: Up to 12 months)
- Total count of participants receiving post-procedural care from the treating physician (Time frame: Up to 12 months)
Supervision of the CURVE-PD trial is entrusted to a steering committee composed of the following individuals:
Dr. Mohit Khera, President of the Sexual Medicine Society of North America, emphasized the plight of individuals with Peyronie's disease, stating, "Given that Peyronie's disease does not pose a significant threat to one's life and due to the stigma surrounding the condition, many individuals who suffer from Peyronie's may refrain from seeking medical attention, resulting in an inadequate amount of data on the subject. This groundbreaking registry will promote a more comprehensive understanding of treatment and management through the use of real-world evidence."
The estimated completion date for the study is May 2025.
"We are delighted to contribute to the advancement of knowledge concerning Peyronie's disease and its treatments so that patients can benefit from a more thorough understanding of their options in the future," commented Dr. Gregory Kaufman, Vice President of Medical Affairs and Chief Medical Officer at Endo.1 "Endo is steadfast in its commitment to supporting the Peyronie's patient community, in collaboration with our esteemed partners on the study steering committee."
Endo reports that approximately one out of every ten men in the United States experiences Peyronie's disease.1
1. Endo Announces First Patient Enrolled in Registry of Peyronie's Disease. Published online July 20, 2023. Accessed July 20, 2023. https://www.prnewswire.com/news-releases/endo-announces-first-patient-enrolled-in-registry-of-peyronies-disease-301881303.html
2. Study on Real-World Data Conducted by the NIH US National Library of Medicine's ClinicalTrials.gov to Gain Insight into the Efficacy of Treatments for Peyronie's Disease (CURVE-PD). Last Updated on May 24, 2023. Visit https://classic.clinicaltrials.gov/ct2/show/NCT05873595 for more details.
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