Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-03-04 @ 4:58 AM
Study NCT ID:
NCT02213757
Status:
TERMINATED
Last Update Posted:
2023-03-15
First Post:
2014-08-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006417', 'term': 'Hematuria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lee.Ann.Richter@medstar.net', 'phone': '2028776526', 'title': 'Dr. Richter', 'organization': 'MHRI'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Premarin Vaginal Cream', 'description': 'Premarin vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPremarin vaginal estrogen cream', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Vaginal Cream', 'description': 'Placebo vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPlacebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Resolution of Microscopic Hematuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Premarin Vaginal Cream', 'description': 'Premarin vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPremarin vaginal estrogen cream'}, {'id': 'OG001', 'title': 'Placebo Vaginal Cream', 'description': 'Placebo vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPlacebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Microscopic urinalysis will be performed after an 8 week trial of vaginal estrogen or placebo. Resolution of microscopic hematuria is defined according to AUA guidelines, \\<3 red blood cells per high powered field.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 14 participants in Placebo arm, 10 completed study and 4 were lost to follow up. 6 in Placebo group had resolution of microhematuria.\n\nThere were 15 participants in Estrogen arm, 10 completed study and 5 were lost to follow up. 10 in Estrogen group had resolution of microhematuria.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement in Symptoms of Urinary Frequency and Urgency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Premarin Vaginal Cream', 'description': 'Premarin vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPremarin vaginal estrogen cream'}, {'id': 'OG001', 'title': 'Placebo Vaginal Cream', 'description': 'Placebo vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPlacebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'To determine the effect of vaginal estrogen compared to placebo on symptoms of urinary frequency and urgency. Participants that experience at least one point reduction in OAB-q score will qualify as a participant with improvement in these symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OAB-q scores were collected at baseline and at follow-up. Subjects with at least one point reduction in OAB-q score were recorded to show improvement in OAB-q score. Seven participants in the test group showed a reduction of at least 1 point and seven participants in the control group showed a reduction of at least 1 point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Premarin Vaginal Cream', 'description': 'Premarin vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPremarin vaginal estrogen cream'}, {'id': 'FG001', 'title': 'Placebo Vaginal Cream', 'description': 'Placebo vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPlacebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Premarin Vaginal Cream', 'description': 'Premarin vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPremarin vaginal estrogen cream'}, {'id': 'BG001', 'title': 'Placebo Vaginal Cream', 'description': 'Placebo vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.\n\nPlacebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Low Enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2014-08-08', 'resultsFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2014-08-08', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-13', 'studyFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Resolution of Microscopic Hematuria', 'timeFrame': '8 weeks', 'description': 'Microscopic urinalysis will be performed after an 8 week trial of vaginal estrogen or placebo. Resolution of microscopic hematuria is defined according to AUA guidelines, \\<3 red blood cells per high powered field.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Improvement in Symptoms of Urinary Frequency and Urgency', 'timeFrame': '8 weeks', 'description': 'To determine the effect of vaginal estrogen compared to placebo on symptoms of urinary frequency and urgency. Participants that experience at least one point reduction in OAB-q score will qualify as a participant with improvement in these symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hematuria', 'Menopause', 'Urinalysis'], 'conditions': ['Microscopic Hematuria']}, 'referencesModule': {'references': [{'pmid': '16579943', 'type': 'BACKGROUND', 'citation': 'Wu JM, Williams KS, Hundley AF, Jannelli ML, Visco AG. Microscopic hematuria as a predictive factor for detecting bladder cancer at cystoscopy in women with irritative voiding symptoms. Am J Obstet Gynecol. 2006 May;194(5):1423-6. doi: 10.1016/j.ajog.2006.01.053. Epub 2006 Mar 30.'}, {'pmid': '22453223', 'type': 'BACKGROUND', 'citation': 'Shalom DF, Lin SN, St Louis S, Lind LR, Winkler HA. The prevalence of microscopic hematuria in women with pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2011 Nov;17(6):290-2. doi: 10.1097/SPV.0b013e3182357afb.'}, {'pmid': '21419446', 'type': 'BACKGROUND', 'citation': 'Jung H, Gleason JM, Loo RK, Patel HS, Slezak JM, Jacobsen SJ. Association of hematuria on microscopic urinalysis and risk of urinary tract cancer. J Urol. 2011 May;185(5):1698-703. doi: 10.1016/j.juro.2010.12.093. Epub 2011 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if vaginal estrogen use is associated with resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The hypothesis is that postmenopausal women with blood in the urine (microscopic hematuria) will have higher rates of resolution of hematuria after treatment course with vaginal conjugated equine estrogen cream compared to placebo cream', 'detailedDescription': 'This is a randomized controlled trial of vaginal estrogen cream for postmenopausal women with microscopic hematuria (AMH). Potential subjects will be screened with a dipstick urinalysis of a catheterized urine specimen, followed by microscopic urinalysis and urine culture if urine dipstick is positive for trace blood or greater. Women who are identified as having asymptomatic microscopic hematuria (\\>3 red blood cells (RBC) per high powered field (hpf)) on a single urine microscopy specimen in the absence of urinary tract infection or other benign cause will be eligible for enrollment.\n\nWomen meeting inclusion criteria will be randomized to either conjugated equine estrogen cream (Premarin, 0.625mg conjugated estrogens) or placebo cream for 8 weeks. Microscopic urinalysis of a catheterized urine specimen will be re-checked at 8 weeks to check for reduction, resolution or persistence of AMH. During the 8 weeks of vaginal estrogen or placebo, women will complete the recommended AMH workup as dictated by the American Urologic Association (AUA) guidelines (cystourethroscopy, serum blood urea nitrogen and creatinine levels, and computed tomography (CT) scan of the abdomen and pelvis with and without intravenous contrast).1\n\nValidated questionnaires to assess vaginal atrophy and symptoms of urinary urgency and frequency will be completed at time of randomization and again at 8 weeks. Cost analysis of the standard AMH workup (cystourethroscopy and CT scan) versus empiric treatment with 8 weeks of vaginal estrogen cream will be calculated based on Medicare reimbursement, as well as market price for vaginal estrogen cream Additionally, patients will be asked to complete a questionnaire to assess the level of bother associated with completing the current AMH workup of CT scan and cystoscopy as compared to completing a treatment course of vaginal estrogen cream.\n\nSecondary analyses will determine whether there are additional benefits to a trial period of vaginal estrogen cream in postmenopausal women with AMH prior to reflexively screening for urinary tract abnormalities. We will compare the cost of a standard AMH workup to a treatment course of vaginal estrogen cream, to determine whether vaginal estrogen with potential resolution of AMH is associated with any savings prior to pursuing further workup. Additionally, questionnaires will ask study participants whether they would prefer to undergo the current AUA AMH workup or a treatment course of vaginal cream, in order to assess bother and anxiety associated with these interventions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal women\n* Asymptomatic microscopic hematuria (three or more red blood cells per high powered field on a single urine microscopy) in the absence of urinary tract infection.\n\nExclusion Criteria:\n\n* Known urologic disease\n* Presence of gross hematuria\n* Presence of indwelling urologic foreign body (foley catheter, ureteral stent)\n* Inability to obtain intravenous contrast CT scan (elevated creatinine, severe contrast allergy)\n* History of pelvic irradiation or malignancy\n* Not a candidate for vaginal estrogen\n\n * Allergy to vaginal estrogen\n * Current or prior diagnosis of breast or endometrial cancer\n * History of deep vein thrombosis/pulmonary embolus\n * Hypercoagulable state'}, 'identificationModule': {'nctId': 'NCT02213757', 'acronym': 'EVER', 'briefTitle': 'Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH): A Randomized Controlled Trial [EVER Study]', 'orgStudyIdInfo': {'id': '2014-071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Premarin vaginal cream', 'description': 'Premarin vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.', 'interventionNames': ['Drug: Premarin vaginal estrogen cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo vaginal cream', 'description': 'Placebo vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.', 'interventionNames': ['Drug: Placebo vaginal cream']}], 'interventions': [{'name': 'Premarin vaginal estrogen cream', 'type': 'DRUG', 'otherNames': ['Conjugated estrogens vaginal cream'], 'armGroupLabels': ['Premarin vaginal cream']}, {'name': 'Placebo vaginal cream', 'type': 'DRUG', 'otherNames': ['Other names have not been specified'], 'description': 'Inactive vaginal cream manufactured to mimic Premarin vaginal cream', 'armGroupLabels': ['Placebo vaginal cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20001', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Cheryl B Iglesia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medstar Health Research Institute'}, {'name': 'Lee A Richter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medstar Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}