Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00156156
Status:
COMPLETED
Last Update Posted:
2008-05-28
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Asoprisnil in the Treatment of 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-27', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2008-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term Safety.', 'timeFrame': 'Throughout 2 year treatment period'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the monthly bleeding score and the number of days with bleeding.', 'timeFrame': 'Each Month'}, {'measure': 'Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.', 'timeFrame': 'Months 3, 6, 9,12,15,18, 24'}, {'measure': 'Percent change from baseline in volume of the largest fibroid.', 'timeFrame': 'Months 12, 24'}, {'measure': 'Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.', 'timeFrame': 'Months 6, 12, 18, 24'}, {'measure': 'Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.', 'timeFrame': 'Months 6, 12, 18, 24'}, {'measure': 'Change from baseline in the 8 scales of the SF-36 questionnaire.', 'timeFrame': 'Months 6, 12, 18, 24'}, {'measure': 'Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire.', 'timeFrame': 'Months 6, 12, 18, 24'}, {'measure': 'Cumulative percent of subjects who achieve amenorrhea.', 'timeFrame': 'Each Month'}]}, 'oversightModule': {'oversightHasDmc': False}, '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 long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.', 'detailedDescription': 'No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab values and vital signs.\n\nSome subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment\n* Otherwise in good health\n* Premenopausal based on Estrogen and FSH levels\n* Adequate endometrial biopsy with no significant histological disorder\n* Agrees to use double-barrier method of contraception\n\nExclusion Criteria:\n\n* Any abnormal lab or procedure result(s) the study-doctor considers important\n* History of a blood-clotting disorder\n* History of osteoporosis requiring treatment\n* Any invasive procedure(s) (D\\&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study\n* Hemoglobin \\< 8.0 g/dL\n* Endometrial thickness ≥ 19 mm'}, 'identificationModule': {'nctId': 'NCT00156156', 'briefTitle': 'Study of Asoprisnil in the Treatment of Uterine Fibroids.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata', 'orgStudyIdInfo': {'id': 'A-FB04-078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Asoprisnil']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Asoprisnil']}], 'interventions': [{'name': 'Asoprisnil', 'type': 'DRUG', 'otherNames': ['J867'], 'description': 'Asoprisnil 10 mg Tablet, oral Daily for up to 2 years', 'armGroupLabels': ['1']}, {'name': 'Asoprisnil', 'type': 'DRUG', 'otherNames': ['J867'], 'description': 'Asoprisnil 25 mg Tablet, oral Daily for up to 2 years', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Cynthia Mattia-Goldberg', 'oldOrganization': 'Abbott'}}}}