Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-27 @ 12:35 AM
Study NCT ID:
NCT01156857
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2010-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-06-28', 'releaseDate': '2019-04-04'}, {'resetDate': '2019-09-27', 'releaseDate': '2019-09-02'}], 'estimatedResultsFirstSubmitDate': '2019-04-04'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555622', 'term': 'ulipristal acetate'}, {'id': 'D011372', 'term': 'Progestins'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-14', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-02', 'lastUpdatePostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy endpoints', 'timeFrame': 'From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.', 'description': 'Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).'}, {'measure': 'Number and proportion of subjects experiencing open label treatment-emergent adverse events', 'timeFrame': 'From baseline to end of PGL4001 treatment (3months treatment)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Uterine Fibroids']}, 'referencesModule': {'references': [{'pmid': '24630081', 'type': 'DERIVED', 'citation': 'Donnez J, Vazquez F, Tomaszewski J, Nouri K, Bouchard P, Fauser BC, Barlow DH, Palacios S, Donnez O, Bestel E, Osterloh I, Loumaye E; PEARL III and PEARL III Extension Study Group. Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertil Steril. 2014 Jun;101(6):1565-73.e1-18. doi: 10.1016/j.fertnstert.2014.02.008. Epub 2014 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.', 'detailedDescription': 'PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.\n* Subject with a Body Mass Index ≥18 and ≤40.\n* Subject with myomatous uterus size \\< 16 weeks.\n* Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.\n* Subject complained of strong uterine bleeding.\n* Subject is eligible for hysterectomy or myomectomy.\n* Females of childbearing potential have to practice a non-hormonal method of contraception.\n\nExclusion Criteria:\n\n* Subject has a history of or current uterus, cervix, ovarian or breast cancer.\n* Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.\n* Subject has a known severe coagulation disorder.\n* Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.\n* Subject has abnormal hepatic function at study entry.'}, 'identificationModule': {'nctId': 'NCT01156857', 'acronym': 'PEARLIII', 'briefTitle': 'PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata', 'organization': {'class': 'INDUSTRY', 'fullName': 'PregLem SA'}, 'officialTitle': 'A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.', 'orgStudyIdInfo': {'id': 'PGL09-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).', 'interventionNames': ['Drug: PGL4001, placebo']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).', 'interventionNames': ['Drug: PGL4001, progestin']}], 'interventions': [{'name': 'PGL4001, placebo', 'type': 'DRUG', 'otherNames': ['Ulipristal acetate'], 'description': 'PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).', 'armGroupLabels': ['A']}, {'name': 'PGL4001, progestin', 'type': 'DRUG', 'otherNames': ['Ulipristal acetate'], 'description': 'PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8047', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University Graz, department of obstetrics and gynecology', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University Vienna, department of obstetrics and gynecology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHR de la citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Cliniques Universitaires UCL de Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '15-224', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Prywatna Klinika Polozniczo-Ginekologiczna', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-895', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'INVICTA Sp. Z o.o.', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40-724', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Private Practice', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '90-602', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Private Practice', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '00-815', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Private Practice', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-066', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Private Practice', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-369', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Institut Universitari Dexeus Departamento de Ginecología', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Hebron, gynecology department', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i provincial de Barcelona, gynecology department', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '13005', 'city': 'Ciudad Real', 'country': 'Spain', 'facility': 'Hospital General de Ciudad Real Gynecology', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'zip': '19002', 'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0)', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '27002', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Clinica Ginecologica CEOGA, departamento de Ginecologia', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Private pratice', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital universitario 12 de Octubre, departamento de ginecologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'CHIP', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PregLem SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-04-04', 'type': 'RELEASE'}, {'date': '2019-06-28', 'type': 'RESET'}, {'date': '2019-09-02', 'type': 'RELEASE'}, {'date': '2019-09-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'PregLem SA'}}}}