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

Peyronie's Disease Clinical Trial

— CURVE-PD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05873595
• Other study ID #: EP02REG
• Status: Terminated
• Start date: June 20, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: April 2024
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Penile Induration
• Peyronie's Disease

Locations

Country	Name	City	State
United States	Endo Pharmaceuticals Clinical Site 7	Gahanna	Ohio
United States	Endo Pharmaceuticals Clinical Site 6	Greenwood	Indiana
United States	Endo Pharmaceuticals Clinical Site 4	Houston	Texas
United States	Endo Pharmaceuticals Clinical Site 5	Lansing	Michigan
United States	Endo Pharmaceuticals Clinical Site 3	Miami	Florida
United States	Endo Pharmaceuticals Clinical Site 1	Orem	Utah
United States	Endo Pharmaceuticals Clinical Site 2	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Receiving Each Treatment Type for PD		Up to 12 months
Secondary	Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score		Up to 12 months
Secondary	Change from Baseline in International Index of Erectile Function (IIEF) Score		Up to 12 months
Secondary	Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score		Up to 12 months
Secondary	Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score		Up to 12 months
Secondary	Participant Satisfaction Questionnaire		Up to 12 months
Secondary	Number of Participants Receiving Post-Procedural Care by the Treating Physician		Up to 12 months