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

NCT05873595 — Terminated, 29 participants, Endo USA Inc., a Keenova Therapeutics Company

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

RegistryNCT05873595, acronym CURVE-PD
StatusTerminated - Endo determined to discontinue its registries and the CURVE registry enrollment has been closed.
Study typeObservational
Enrollment29 (Actual)
SponsorEndo USA Inc., a Keenova Therapeutics Company (Industry)
ConditionsPeyronie's Disease
Datesstart 2023-06-20, primary completion 2024-02-26, completion 2024-02-26, first posted 2023-05-24, last updated 2024-04-16
Locations7 sites in United States

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-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.

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+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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: Male, ages: 18 Years to any

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.

+Locations (7)

FacilityCityCountryStatus
Endo Pharmaceuticals Clinical Site 2San Diego, CaliforniaUnited States
Endo Pharmaceuticals Clinical Site 3Miami, FloridaUnited States
Endo Pharmaceuticals Clinical Site 6Greenwood, IndianaUnited States
Endo Pharmaceuticals Clinical Site 5Lansing, MichiganUnited States
Endo Pharmaceuticals Clinical Site 7Gahanna, OhioUnited States
Endo Pharmaceuticals Clinical Site 4Houston, TexasUnited States
Endo Pharmaceuticals Clinical Site 1Orem, UtahUnited States

+Investigators

  • Medical Information, Study director, Endo USA Inc., a Keenova Therapeutics Company