Clinical trial NCT05873595: Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease
Official title: Clinical Understanding Through Real-world Data to Validate Effectiveness of Treatments in Peyronie's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peyronie's Disease
Keywords: Real world data
Retrospective
Prospective
Registry
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a confirmed diagnosis of PD will be enrolled in the United States.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Receiving Each Treatment Type for PD
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score
timeFrame: Up to 12 months
measure: Change from Baseline in International Index of Erectile Function (IIEF) Score
timeFrame: Up to 12 months
measure: Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Up to 12 months
measure: Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score
timeFrame: Up to 12 months
measure: Participant Satisfaction Questionnaire
timeFrame: Up to 12 months
measure: Number of Participants Receiving Post-Procedural Care by the Treating Physician
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Endo Pharmaceuticals Clinical Site 2
state: California
city: Miami
country: United States
facility: Endo Pharmaceuticals Clinical Site 3
state: Florida
city: Greenwood
country: United States
facility: Endo Pharmaceuticals Clinical Site 6
state: Indiana
city: Lansing
country: United States
facility: Endo Pharmaceuticals Clinical Site 5
state: Michigan
city: Gahanna
country: United States
facility: Endo Pharmaceuticals Clinical Site 7
state: Ohio
city: Houston
country: United States
facility: Endo Pharmaceuticals Clinical Site 4
state: Texas
city: Orem
country: United States
facility: Endo Pharmaceuticals Clinical Site 1
state: Utah
Study officials:
affiliation: Endo Pharmaceuticals
name: Medical Information
role: STUDY_DIRECTOR
References: