Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-28 @ 11:00 PM
Study NCT ID:
NCT01533532
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2012-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716911', 'term': 'linzagolix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-29', 'studyFirstSubmitDate': '2012-02-12', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The severity score of the pelvic pain', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gonadotropin-Releasing Hormone (GnRH) antagonist'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with endometriosis\n\nExclusion Criteria:\n\n* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction'}, 'identificationModule': {'nctId': 'NCT01533532', 'briefTitle': 'A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Placebo-controlled, Double-blind Phase II Study of KLH-2109 in Patients With Endometriosis(2)', 'orgStudyIdInfo': {'id': 'KLH1202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KLH-2109, low dose', 'interventionNames': ['Drug: KLH-2109']}, {'type': 'EXPERIMENTAL', 'label': 'KLH-2109, medium dose', 'interventionNames': ['Drug: KLH-2109']}, {'type': 'EXPERIMENTAL', 'label': 'KLH-2109, high dose', 'interventionNames': ['Drug: KLH-2109']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'KLH-2109', 'type': 'DRUG', 'armGroupLabels': ['KLH-2109, low dose']}, {'name': 'KLH-2109', 'type': 'DRUG', 'armGroupLabels': ['KLH-2109, medium dose']}, {'name': 'KLH-2109', 'type': 'DRUG', 'armGroupLabels': ['KLH-2109, high dose']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo and Other Japanese City', 'country': 'Japan', 'facility': 'Japan'}], 'overallOfficials': [{'name': 'Tatsuro Takei', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}