Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-26 @ 3:43 PM
Study NCT ID:
NCT00152256
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2005-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}], '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'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C488516', 'term': 'asoprisnil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-27', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2008-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative percent of subjects achieving amenorrhea.', 'timeFrame': 'Month 3'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.', 'timeFrame': 'Final Visit'}, {'measure': 'Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.', 'timeFrame': 'Final Visit'}, {'measure': 'Change from baseline in the Work Limitation Questionnaire Index.', 'timeFrame': 'Final Visit'}, {'measure': 'Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).', 'timeFrame': 'Final Visit'}, {'measure': 'Change from baseline in the monthly bleeding score.', 'timeFrame': 'Final Visit'}, {'measure': 'Change from baseline in the hemoglobin concentration.', 'timeFrame': 'Final Visit'}, {'measure': 'Change from baseline in volume of the largest fibroid.', 'timeFrame': 'Final Visit'}, {'measure': 'Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment.', 'timeFrame': 'During treatment period'}, {'measure': 'Percentage of subjects who respond positively to the global efficacy question.', 'timeFrame': 'Final Visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Symptomatic Uterine Fibroids', 'Excessive Uterine Bleeding', 'Uterine Hemorrhage'], 'conditions': ['Fibroid Uterus', 'Leiomyoma', 'Menorrhagia', 'Metrorrhagia', 'Uterine Fibroids']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.', 'detailedDescription': 'No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '53 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal women\n* History of regular menstrual cycles (21-42 days)\n* Diagnosis of uterine fibroid(s)\n* Abnormal vaginal bleeding associated with uterine fibroids\n* Otherwise in good health\n* Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3\n\nExclusion Criteria:\n\n* Less than 3 months postpartum and post-lactation\n* Previous myomectomy within 1 year\n* Any abnormal lab or procedure result the study-doctor considers important\n* Severe reaction(s) to or are currently using any hormone therapy\n* History of osteoporosis or other bone disease'}, 'identificationModule': {'nctId': 'NCT00152256', 'briefTitle': 'A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata', 'orgStudyIdInfo': {'id': 'C02-037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Asoprisnil']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Asoprisnil']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Asoprisnil', 'type': 'DRUG', 'otherNames': ['J867'], 'description': 'Asoprisnil 10 mg Tablet, oral Daily for 6 months', 'armGroupLabels': ['1']}, {'name': 'Asoprisnil', 'type': 'DRUG', 'otherNames': ['J867'], 'description': 'Asoprisnil 25mg Tablet, oral Daily for 6 months', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Tablet, oral Daily for 6 months', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Cynthia Mattia-Goldberg', 'oldOrganization': 'Abbott'}}}}