Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease (CURVE-PD)

April 13, 2024 updated by: Endo Pharmaceuticals

Clinical Understanding Through Real-world Data to Validate Effectiveness of Treatments in Peyronie's Disease

This is an observational study, meaning participants will not receive any investigational treatment as part of this study.

Researchers will collect real-world data (RWD) to gain a more in-depth knowledge of the treatment of Peyronie's Disease (PD) to evaluate the management of PD.

Study Overview

Status

Terminated

Conditions

Detailed Description

Each participant of the study will have their data collected from the date of confirmed diagnosis of PD to the date of enrollment in the registry, post consent. Data will be collected from the participant's clinical records as well as from the participant directly. Data will be collected through Pulse Infoframe's technology platform.

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • Endo Pharmaceuticals Clinical Site 2
    • Florida
      • Miami, Florida, United States, 33136
        • Endo Pharmaceuticals Clinical Site 3
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Endo Pharmaceuticals Clinical Site 6
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Endo Pharmaceuticals Clinical Site 5
    • Ohio
      • Gahanna, Ohio, United States, 43230
        • Endo Pharmaceuticals Clinical Site 7
    • Texas
      • Houston, Texas, United States, 77030
        • Endo Pharmaceuticals Clinical Site 4
    • Utah
      • Orem, Utah, United States, 84057
        • Endo Pharmaceuticals Clinical Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with a confirmed diagnosis of PD will be enrolled in the United States.

Description

Key Inclusion Criteria:

  • Any adult with a confirmed clinical diagnosis of PD.
  • Age 18 years (or age of majority in their jurisdiction) or older at time of enrollment.
  • Willing to participate in the registry (including completion of ePROs) and complete the informed consent form.
  • Having received PD treatment within 2 weeks before enrollment, at enrollment or any time after the date of enrollment. After a confirmed diagnosis of PD, not having received PD treatment.
  • Able to participate in English based registry.

Key Exclusion criteria:

  • Not having a clinical diagnosis of PD.
  • Age less than 18 years.
  • Do not provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Receiving Each Treatment Type for PD
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score
Time Frame: Up to 12 months
Up to 12 months
Change from Baseline in International Index of Erectile Function (IIEF) Score
Time Frame: Up to 12 months
Up to 12 months
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Time Frame: Up to 12 months
Up to 12 months
Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score
Time Frame: Up to 12 months
Up to 12 months
Participant Satisfaction Questionnaire
Time Frame: Up to 12 months
Up to 12 months
Number of Participants Receiving Post-Procedural Care by the Treating Physician
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Investigators

  • Study Director: Medical Information, Endo Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Actual)

February 26, 2024

Study Completion (Actual)

February 26, 2024

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP02REG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peyronie's Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe