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

Sponsor
Endo Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05873595
Collaborator
(none)
1,000
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Clinical Understanding Through Real-world Data to Validate Effectiveness of Treatments in Peyronie's Disease
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    May 1, 2025
    Anticipated Study Completion Date :
    May 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Receiving Each Treatment Type for PD [Up to 12 months]

    Secondary Outcome Measures

    1. Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score [Up to 12 months]

    2. Change from Baseline in International Index of Erectile Function (IIEF) Score [Up to 12 months]

    3. Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score [Up to 12 months]

    4. Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score [Up to 12 months]

    5. Participant Satisfaction Questionnaire [Up to 12 months]

    6. Number of Participants Receiving Post-Procedural Care by the Treating Physician [Up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Endo Pharmaceuticals

    Investigators

    • Study Director: Medical Information, Endo Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Endo Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05873595
    Other Study ID Numbers:
    • EP02REG
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Keywords provided by Endo Pharmaceuticals
    Real world data
    Retrospective
    Prospective
    Registry
    Additional relevant MeSH terms:
    Penile Induration

    Study Results

    No Results Posted as of May 24, 2023