NCT05873595

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

May 15, 2023

Last Update Submit

April 13, 2024

Conditions

Keywords

Real world dataRetrospectiveProspectiveRegistry

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Receiving Each Treatment Type for PD

    Up to 12 months

Secondary Outcomes (6)

  • Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score

    Up to 12 months

  • Change from Baseline in International Index of Erectile Function (IIEF) Score

    Up to 12 months

  • Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score

    Up to 12 months

  • Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score

    Up to 12 months

  • Participant Satisfaction Questionnaire

    Up to 12 months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Endo Pharmaceuticals Clinical Site 2

San Diego, California, 92120, United States

Location

Endo Pharmaceuticals Clinical Site 3

Miami, Florida, 33136, United States

Location

Endo Pharmaceuticals Clinical Site 6

Greenwood, Indiana, 46143, United States

Location

Endo Pharmaceuticals Clinical Site 5

Lansing, Michigan, 48912, United States

Location

Endo Pharmaceuticals Clinical Site 7

Gahanna, Ohio, 43230, United States

Location

Endo Pharmaceuticals Clinical Site 4

Houston, Texas, 77030, United States

Location

Endo Pharmaceuticals Clinical Site 1

Orem, Utah, 84057, United States

Location

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Medical Information

    Endo Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 24, 2023

Study Start

June 20, 2023

Primary Completion

February 26, 2024

Study Completion

February 26, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations