Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT00152269
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Uterine Fibroids With Asoprisnil(J867)
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': 475}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2005-01', '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': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention.', 'timeFrame': 'Month 12 or Final Visit'}], 'secondaryOutcomes': [{'measure': 'Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.', 'timeFrame': 'Month 6'}, {'measure': 'Change from baseline in menstrual pictogram score.', 'timeFrame': 'Final Month'}, {'measure': 'Change from baseline in number of days with bleeding.', 'timeFrame': 'Final Month'}, {'measure': 'Change from baseline in hemoglobin concentration.', 'timeFrame': 'Final Visit'}, {'measure': 'Percent change from baseline in volume of the largest fibroid.', 'timeFrame': 'Final Visit'}, {'measure': 'Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.', 'timeFrame': 'Final Visit'}, {'measure': 'Change from baseline in total symptom severity score and UFS-QOL total score.', 'timeFrame': 'Final Visit'}, {'measure': 'Cumulative percent of subjects who achieve amenorrhea.', 'timeFrame': 'Month 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Symptomatic Uterine Fibroids', 'Excessive Uterine Bleeding', 'Uterine Hemorrhage', 'asoprisnil'], 'conditions': ['Leiomyoma', 'Menorrhagia', 'Metrorrhagia']}, 'referencesModule': {'references': [{'pmid': '30865281', 'type': 'DERIVED', 'citation': 'Stewart EA, Diamond MP, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. Safety and efficacy of the selective progesterone receptor modulator asoprisnil for heavy menstrual bleeding with uterine fibroids: pooled analysis of two 12-month, placebo-controlled, randomized trials. Hum Reprod. 2019 Apr 1;34(4):623-634. doi: 10.1093/humrep/dez007.'}, {'pmid': '23188490', 'type': 'DERIVED', 'citation': 'Larsen L, Coyne K, Chwalisz K. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding. Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic 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 safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], '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* Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails\n* Negative pregnancy test\n* Agrees to Double-barrier method of contraception\n* Pap smear with no evidence of malignancy or pre-malignant changes\n* Endometrial biopsy with no significant histological disorder\n\nExclusion Criteria:\n\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\n* Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months\n* History of Polycystic Ovary Syndrome or prolactinoma\n* MRI shows significant gynecologic disorder\n* Uterine size \\> 25 weeks gestation\n* Hemoglobin \\< 8 g/dL at Day -1'}, 'identificationModule': {'nctId': 'NCT00152269', 'briefTitle': 'Treatment of Uterine Fibroids With Asoprisnil(J867)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety (Including Bone Density Assessment) of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata', 'orgStudyIdInfo': {'id': 'M01-390'}}, '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', 'description': '10mg Tablet, oral Daily for 12 months', 'armGroupLabels': ['1']}, {'name': 'Asoprisnil', 'type': 'DRUG', 'description': '25mg Tablet, oral Daily for 12 months', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, Tablet, oral Daily for 12 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'}}}}