ClinicalTrials.gg
TerminatedNCT05873595CURVE-PDUpdated Apr 16, 2024

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

An observational study in Peyronie's Disease, sponsored by Endo Pharmaceuticals. Terminated at 7 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Observational

Why this study was terminated
Endo determined to discontinue its registries and the CURVE registry enrollment has been closed.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
29
Ages
18 Years and older
Sex
Male
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Study 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.

Read the 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.

02

Conditions studied

  • Peyronie's Disease

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Keywords

  • Real world data
  • Retrospective
  • Prospective
  • Registry
03

In context

Penile Induration

47 studies on the registry are indexed under Penile Induration; 10 are open to participants now.

Browse Penile Induration studies →

Lead sponsor

Endo Pharmaceuticals is the lead sponsor of 99 studies on the registry; none are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
29 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Number of Participants Receiving Each Treatment Type for PD

    Time frame: Up to 12 months

Secondary outcomes

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

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

  5. Participant Satisfaction Questionnaire

    Time frame: Up to 12 months

  6. Number of Participants Receiving Post-Procedural Care by the Treating Physician

    Time frame: Up to 12 months

07

Study locations

7 sites
  • Endo Pharmaceuticals Clinical Site 2
    San Diego, California 92120, United States
  • Endo Pharmaceuticals Clinical Site 3
    Miami, Florida 33136, United States
  • Endo Pharmaceuticals Clinical Site 6
    Greenwood, Indiana 46143, United States
  • Endo Pharmaceuticals Clinical Site 5
    Lansing, Michigan 48912, United States
  • Endo Pharmaceuticals Clinical Site 7
    Gahanna, Ohio 43230, United States
  • Endo Pharmaceuticals Clinical Site 4
    Houston, Texas 77030, United States
  • Endo Pharmaceuticals Clinical Site 1
    Orem, Utah 84057, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Feb 2024, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2023
First posted
May 24, 2023
StartActual
Jun 20, 2023
Primary completionActual
Feb 26, 2024
CompletionActual
Feb 26, 2024
Last update
Apr 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05873595
Responsible party
Sponsor
First posted
May 24, 2023
Start date
Jun 20, 2023
Primary completion
Feb 26, 2024
Completion
Feb 26, 2024
Last update
Apr 16, 2024

Study contacts

Medical Information
study director · Endo Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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