Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05445167
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2022-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716911', 'term': 'linzagolix'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-15', 'size': 757484, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-03T21:11', 'hasProtocol': True}, {'date': '2024-06-26', 'size': 337085, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-03T21:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration', 'timeFrame': 'Up to 12 weeks', 'description': 'PBAC (pictorial blood loss assessment chart) score'}, {'measure': 'Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration', 'timeFrame': 'Up to 12 weeks', 'description': 'NRS (numeric rating scale) for pain'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration', 'timeFrame': 'Up to 12 weeks', 'description': 'PBAC (pictorial blood loss assessment chart) score'}, {'measure': 'Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration', 'timeFrame': 'Up to 12 weeks', 'description': 'PBAC (pictorial blood loss assessment chart) score'}, {'measure': 'Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days', 'timeFrame': 'Up to 12 weeks', 'description': 'NRS (numerical rating scale)'}, {'measure': 'Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration', 'timeFrame': 'Up to 12 weeks', 'description': 'NRS (numerical rating scale)'}, {'measure': 'Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days', 'timeFrame': 'Up to 12 weeks', 'description': 'NRS (numerical rating scale)'}, {'measure': 'Average NRS score every 28 days for pain symptoms', 'timeFrame': 'Up to 12 weeks', 'description': 'NRS (numerical rating scale)'}, {'measure': 'Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) during 28 days before end of study drug administration', 'timeFrame': 'Up to 12 weeks', 'description': 'NRS (numerical rating scale)'}, {'measure': 'Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days', 'timeFrame': 'Up to 12 weeks', 'description': 'NRS (numerical rating scale)'}, {'measure': 'Incidence of adverse events and adverse drug reactions', 'timeFrame': 'Up to 12 weeks', 'description': 'Adverse events and adverse drug reactions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Fibroids (MeSH Heading: Leiomyoma)']}, 'descriptionModule': {'briefSummary': 'Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal Japanese woman diagnosed with uterine fibroids\n* Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:\n* Larger than a certain standard\n* No calcification\n* Not receiving surgical treatment\n* Patients with a normal menstrual cycle\n* Patients diagnosed with menorrhagia\n* Patients with pain symptoms associated with uterine fibroids\n\nExclusion Criteria:\n\n* Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)\n* Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis\n* Patients with undiagnosed abnormal genital bleeding'}, 'identificationModule': {'nctId': 'NCT05445167', 'briefTitle': 'A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain', 'orgStudyIdInfo': {'id': 'KLH2302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KLH-2109', 'interventionNames': ['Drug: KLH-2109']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KLH-2109', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['KLH-2109']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Clinical Research Site'}], 'overallOfficials': [{'name': 'Yoshitaka Shimizu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kissei Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}