Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-09 @ 5:33 AM
Study NCT ID:
NCT05873595
Status:
TERMINATED
Last Update Posted:
2024-04-16
First Post:
2023-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010411', 'term': 'Penile Induration'}], 'ancestors': [{'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Endo determined to discontinue its registries and the CURVE registry enrollment has been closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-13', 'studyFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Receiving Each Treatment Type for PD', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'keywords': ['Real world data', 'Retrospective', 'Prospective', 'Registry'], 'conditions': ["Peyronie's Disease"]}, 'descriptionModule': {'briefSummary': "This is an observational study, meaning participants will not receive any investigational treatment as part of this study.\n\nResearchers 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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a confirmed diagnosis of PD will be enrolled in the United States.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Any adult with a confirmed clinical diagnosis of PD.\n* Age 18 years (or age of majority in their jurisdiction) or older at time of enrollment.\n* Willing to participate in the registry (including completion of ePROs) and complete the informed consent form.\n* 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.\n* Able to participate in English based registry.\n\nKey Exclusion criteria:\n\n* Not having a clinical diagnosis of PD.\n* Age less than 18 years.\n* Do not provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05873595', 'acronym': 'CURVE-PD', 'briefTitle': "Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': "Clinical Understanding Through Real-world Data to Validate Effectiveness of Treatments in Peyronie's Disease", 'orgStudyIdInfo': {'id': 'EP02REG'}}, 'contactsLocationsModule': {'locations': [{'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 2', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 3', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46143', 'city': 'Greenwood', 'state': 'Indiana', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 6', 'geoPoint': {'lat': 39.61366, 'lon': -86.10665}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 5', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '43230', 'city': 'Gahanna', 'state': 'Ohio', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 7', 'geoPoint': {'lat': 40.01923, 'lon': -82.87934}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 4', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84057', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 1', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}], 'overallOfficials': [{'name': 'Medical Information', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}