DUBLIN, July 20, 2023 - Endo International plc (OTC: ENDPQ) announced today that the first patient has been enrolled in CURVE-PD (Clinical Understanding through Real-world data to Validate Effectiveness of treatments in Peyronie's disease), a non-interventional registry of up to 1,000 patients with Peyronie's disease (PD). This registry will create the largest and most comprehensive collection of real-world PD data on treatment outcomes.
PD is a men's health condition that is estimated to affect 1 in 10 men in the U.S.* and can lead to a curvature deformity of the penis when erect.
"We're pleased to help advance knowledge of Peyronie's disease and treatments so that, in the future, patients can benefit from a fuller understanding of their options," said Gregory Kaufman, M.D., Vice President, Medical Affairs and Chief Medical Officer at Endo. "Along with our study steering committee partners, Endo is committed to supporting the Peyronie's patient community."
"Because Peyronie's disease is not a life-threatening disease and due to embarrassment about the condition, many people with Peyronie's may not seek medical attention, which has led to insufficient data on the condition," said Dr. Mohit Khera, M.D., President of the Sexual Medicine Society of North America. "This landmark registry will facilitate more comprehensive knowledge of treatment and management using real-world evidence."
The Study is run by a steering committee that consists of Dr. Mohit Khera, President of the Sexual Medicine Society of North America and Professor of Urology at Baylor College of Medicine; Dr. Jesse Mills, Director of Urology at UCLA Santa Monica Medical Center; and Dr. Ranjith Ramasamy, Director of Reproductive Urology and Associate Professor of Clinical Urology at University of Miami, as well as representatives from Endo and Pulse Infoframe, including Pulse CEO Femida Gwadry-Sridhar, R.Ph., Ph.D.
* Based on a survey of about 7,700 U.S. adult men with a PD diagnosis, PD-related symptoms or a history of seeking treatment for the condition.
About the Study
CURVE-PD (NCT05873595) is a non-interventional study of up to 1,000 PD patients from 15 sites who have initiated treatment within two weeks before, at or any time after the date of enrollment. Patients will be followed for up to one year, and data will be collected from the patients, their healthcare providers and their partners.
Patients will answer questions related to, but not limited to, reasons for treatment choice, self-measurement of curve before and after treatments; ability to participate in sexual activities before and after treatment; in-home stretching/modeling to complement in-office procedures; satisfaction, depression and anxiety scales, including the Peyronie's Disease Questionnaire (PDQ); and patient and partner satisfaction.
Healthcare providers will answer questions related to, but not limited to, reasons for treatment choice, details of treatment, length and curve of penis before and after treatment and location of plaque treated.
About Peyronie's Disease
Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be painful during arousal and intimacy. PD can affect as many as 1 in 10 men in the U.S., but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.
About Endo
Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
About Pulse Infoframe
Pulse Infoframe is a real-world evidence generation, health informatics, and insights company that has built a structured technology and services platform designed to extract, curate, analyze, and disseminate evidence-based conclusions that improve the quality of people's lives. Pulse Infoframe provides a full solution for registries, natural history studies, and other observational and regulatory grade studies. With provider relationships for patient access, Pulse Infoframe ensures that insights, evidence, and publication results are disseminated across the ecosystem, including advocacy organizations, key opinion leaders, researchers, and sponsors. Learn more at www.pulseinfoframe.com.
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SOURCE Endo International plc
