Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-04-23 @ 12:50 AM
Study NCT ID:
NCT02748460
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2016-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1527}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2016-04-19', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of long term safety: Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation', 'timeFrame': 'Patients will be followed from baseline up to 60 months', 'description': 'Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation'}], 'secondaryOutcomes': [{'measure': 'Assessment of Prescription pattern of Esmya in standard medical practice', 'timeFrame': 'Patients will be followed from baseline up to 60 months', 'description': 'Esmya use in patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uterine Fibroids']}, 'descriptionModule': {'briefSummary': 'This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.', 'detailedDescription': 'This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies. It is planned to enrol approximately 1,500 patients. Consecutive, eligible, patients will be invited to enrol from approximately 100-150 European Union (EU) clinical practice sites in approximately 15 countries. Patients will be followed for an observation period of 60 months (5 years) from treatment start. Investigators are to manage and treat patients according to their standard medical practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target study population will include women with moderate to severe symptoms of uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and subjects who were previously exposed to UPA 5 or 10 mg in Long Term Phase III clinical trials PGL09-027 (PEARL III extension; including patients of PGL11-024 (PEARL extension 2)), or PGL11-006 (PEARL IV).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women of reproductive age with a diagnosis of moderate to severe symptoms of uterine fibroids who are not eligible for surgery and for whom a intermittent treatment with Esmya in a long term manner (at least 2 courses), is planned or subjects who were exposed to UPA 5 or 10 mg during long term Phase III trials PGL09-027 (PEARL III extension, including patients (PEARL extension 2)) or PGL11-006 (PEARL IV), and\n* Patient is willing and able to attend visits which are scheduled by her treating physician for the regular follow-up, provide the required medical data, and\n* Patient has personally signed and dated the informed consent document indicating that she has been informed of all pertinent aspects of the study.\n\nExclusion criteria:\n\n* Patient is prescribed Esmya for pre-operative treatment\n* Patient has a contraindication to receive Esmya as per SmPC\n* Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrolment,\n* Patient has hypersensitivity to the active substance of Esmya or to one of its excipients,\n* Not applicable to long term phase III previous subjects who are not planning to receive Esmya during this study:\n\n * Patient is pregnant or plans to become pregnant within the next 12 months from treatment start,\n * Patient is breastfeeding,\n * Patient has genital bleeding of unknown aetiology or not due to uterine fibroids,\n * Patient has been diagnosed with uterine, cervical, ovarian or breast cancer.'}, 'identificationModule': {'nctId': 'NCT02748460', 'acronym': 'Premium', 'briefTitle': 'Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'PregLem SA'}, 'officialTitle': 'Prospective, Multi-national, Multicentre, Non-interventional Study to Evaluate the Long Term Safety of Esmya, in Particular Endometrial Safety, and the Current Prescription and Management Patterns of Esmya in a Long Term Treatment Setting.', 'orgStudyIdInfo': {'id': 'PGL14-001 (PREMIUM)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with Esmya', 'description': 'Any patient who was confirmed as receiving one dose of Esmya'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Regional De La Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Clinique Universitaire de Mont Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Dr Dvorak', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Gyn-Porodnicka Klinika Fn Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Králová', 'country': 'Czechia', 'facility': 'Gyn -Fsro', 'geoPoint': {'lat': 49.76905, 'lon': 17.0344}}, {'city': 'Olomouc', 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North Tees And Hartlepool Nhs Foundation Trust', 'geoPoint': {'lat': 54.56848, 'lon': -1.3187}}, {'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], 'overallOfficials': [{'name': 'Pablo Arriagada', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PregLem SA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PregLem SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}