Peyronie's DiseaseCURVE-PDNCT05873595
Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease
An observational study of Peyronie's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie's Disease
- How many people
- 29 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Jun 2023to 26 Feb 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a confirmed diagnosis of PD will be enrolled in the United States.
Who may be able to join
- 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.
Who cannot join
- Not having a clinical diagnosis of PD.
- Age less than 18 years.
- Do not provide informed consent.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Endo Pharmaceuticals Clinical Site 7
Gahanna, Ohio, 43230
Endo Pharmaceuticals Clinical Site 6
Greenwood, Indiana, 46143
Endo Pharmaceuticals Clinical Site 4
Houston, Texas, 77030
Endo Pharmaceuticals Clinical Site 5
Lansing, Michigan, 48912
Endo Pharmaceuticals Clinical Site 3
Miami, Florida, 33136
Endo Pharmaceuticals Clinical Site 1
Orem, Utah, 84057
Endo Pharmaceuticals Clinical Site 2
San Diego, California, 92120
About this study
Official title: Clinical Understanding Through Real-world Data to Validate Effectiveness of Treatments in Peyronie's Disease
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.
- Conditions
- Peyronie's Disease
- Keywords
- Real world data, Retrospective, Prospective, Registry
- Medical subject headings
- Penile Induration
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Receiving Each Treatment Type for PD
Measured: Up to 12 months
Secondary outcomes (6)
Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score
Measured: Up to 12 months
Change from Baseline in International Index of Erectile Function (IIEF) Score
Measured: Up to 12 months
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Measured: Up to 12 months
Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score
Measured: Up to 12 months
Participant Satisfaction Questionnaire
Measured: Up to 12 months
Number of Participants Receiving Post-Procedural Care by the Treating Physician
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start20 Jun 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Why it stopped: Endo determined to discontinue its registries and the CURVE registry enrollment has been closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 29 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Information, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873595
- Sponsor's protocol ID
- EP02REG
- Acronym
- CURVE-PD
- Status last verified
- Apr 2024
- First submitted
- 15 May 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Understanding Through Real-world Data to Validate Effectiveness of Treatments in Peyronie's Disease
- ClinicalTrials.gov ID
- NCT05873595
- Acronym / sponsor ID
- CURVE-PD / EP02REG
- Conditions
- Peyronie's Disease
- Keywords
- Real world data, Retrospective, Prospective, Registry
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Endo determined to discontinue its registries and the CURVE registry enrollment has been closed.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a confirmed diagnosis of PD will be enrolled in the United States.
Key inclusion criteria (5 listed)
- 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 (3 listed)
- Not having a clinical diagnosis of PD.
- Age less than 18 years.
- Do not provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Receiving Each Treatment Type for PD
Time frame: Up to 12 months
6 secondary outcomes
Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score
Time frame: Up to 12 months
Change from Baseline in International Index of Erectile Function (IIEF) Score
Time frame: Up to 12 months
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Up to 12 months
Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score
Time frame: Up to 12 months
Participant Satisfaction Questionnaire
Time frame: Up to 12 months
Number of Participants Receiving Post-Procedural Care by the Treating Physician
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Endo determined to discontinue its registries and the CURVE registry enrollment has been closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Information study director
Endo USA Inc., a Keenova Therapeutics Company
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peyronie's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Endo determined to discontinue its registries and the CURVE registry enrollment has been closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Receiving Each Treatment Type for PD (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.