Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-04 @ 4:02 AM
Study NCT ID:
NCT00152295
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 Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000568', 'term': 'Amenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C488516', 'term': 'asoprisnil'}, {'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}], 'ancestors': [{'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2001-12', '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': '2001-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.', 'timeFrame': 'Throughout Study'}, {'measure': 'The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System', 'timeFrame': 'Months 3,6'}, {'measure': 'Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.', 'timeFrame': 'Months 3,6'}], 'secondaryOutcomes': [{'measure': 'Frequency and amount of vaginal bleeding assessed via daily diary.', 'timeFrame': 'Throughout study'}, {'measure': 'Frequency and severity of hot flushes assessed via daily diary.', 'timeFrame': 'Throughout study'}, {'measure': 'Mean change from baseline in endocrine determinations.', 'timeFrame': 'Months 2,4,and 6'}, {'measure': 'Global efficacy question', 'timeFrame': 'Month 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postmenopausal', 'Amenorrhea', 'Hormone replacement therapy', 'HRT', 'asoprisnil', 'Estrogen Replacement Therapy, postmenopause'], 'conditions': ['Postmenopause']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg', 'detailedDescription': 'The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '48 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Successful completion of study M00-198\n* Continued good general health\n* Negative urine pregnancy test\n\nExclusion Criteria:\n\n* History of known or suspected cancer other than basal cell carcinoma in last 5 years\n* History of reproductive endocrine disorder\n* Submucous or other symptomatic fibroid which would confound efficacy\n* Ovarian mass\n* Ongoing treatment with an excluded medication\n* Stenosis of the cervix\n* Any abnormal lab result the study-doctor considers significant.'}, 'identificationModule': {'nctId': 'NCT00152295', 'briefTitle': 'A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women', 'orgStudyIdInfo': {'id': 'M01-280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Asoprisnil/Premarin']}], 'interventions': [{'name': 'Asoprisnil/Premarin', 'type': 'DRUG', 'description': '10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Cynthia Mattia-Goldberg', 'oldOrganization': 'Abbott'}}}}