Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-30 @ 6:52 PM
Study NCT ID:
NCT01252069
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-06-27', 'releaseDate': '2019-04-03'}, {'resetDate': '2019-09-26', 'releaseDate': '2019-08-30'}], 'estimatedResultsFirstSubmitDate': '2019-04-03'}}, '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': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-12-01', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received', 'timeFrame': 'From baseline to end of each 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 the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.\n\nThis extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.\n\nExclusion Criteria:\n\n* Subject has a large uterine polyp (\\> 2cm).\n* Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.\n* Subject has abnormal hepatic function at re-test.\n* Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.\n* Subject has a positive pregnancy test or is planning a pregnancy during the course of the study."}, 'identificationModule': {'nctId': 'NCT01252069', 'briefTitle': 'PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'PregLem SA'}, 'officialTitle': 'A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding', 'orgStudyIdInfo': {'id': 'PGL09-027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ended by a drug free period until return of menses.', 'interventionNames': ['Drug: PGL4001, placebo, drug free period']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets) during 3 periods each ended by a drug free period until return of menses.', 'interventionNames': ['Drug: PGL4001, progestin, drug free period']}], 'interventions': [{'name': 'PGL4001, placebo, drug free period', '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) during 3 periods each ending with a drug free period until return of menses.', 'armGroupLabels': ['A']}, {'name': 'PGL4001, progestin, drug free period', '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) during 3 periods each ending with a drug free period until return of menses.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'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 Gynécologie-Obstétrique', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHR de la Citadelle Gynécologie-Obstétrique', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique', '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': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Hebron, gynecology department', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'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 Practice', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'CHIP (Complejo Hospitalario Integral Privado)', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PregLem SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-04-03', 'type': 'RELEASE'}, {'date': '2019-06-27', 'type': 'RESET'}, {'date': '2019-08-30', 'type': 'RELEASE'}, {'date': '2019-09-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'PregLem SA'}}}}