Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-04 @ 7:44 AM
Study NCT ID:
NCT01648751
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'moalpa@upmc.edu', 'phone': '412-641-6052', 'title': 'Pamela Moalli MD PHD', 'organization': 'University of PIttsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Vaginal Estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream\n\nVaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream\n\nPlacebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Global Impression of Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginal Estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream\n\nVaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter.\n\nThe average score on the PGI-I at 6 months post treatment was 2.3. (N=7) A lower score on the PGI-I indicates improvement.'}, {'id': 'OG001', 'title': 'Placebo Cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream\n\nPlacebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter.\n\nThe average score on the PGI-I at 6 months post treatment was 3.0. (N=7) A lower score indicates improvement.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after starting vaginal cream', 'description': 'The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians.\n\nPotential Responses:\n\n1. Very Much Better\n2. Much Better\n3. A Little Better\n4. No Change 5, A Little Worse\n\n6\\. Much Worse 7. Very Much Worse Lower scores indicate more imiprovment / better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed surveys at 6 months post treatment.'}, {'type': 'SECONDARY', 'title': 'Pelvic Floor Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginal Estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream\n\nVaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}, {'id': 'OG001', 'title': 'Placebo Cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream\n\nPlacebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '36'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '130'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Pelvic Floor Symptoms, using the PFDI-20. The Pelvic Floor Distress Inventory is a condition specific quality of life instrument that assesses distress from pelvic organ prolapse, colorectal-anal, and urinary symptoms.\n\nHigher scores indicate greater disease burden. Range: 0 to 300', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed surveys at 6 months post treatment.'}, {'type': 'SECONDARY', 'title': 'General Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginal Estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream\n\nVaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}, {'id': 'OG001', 'title': 'Placebo Cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream\n\nPlacebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24'}, {'value': '19.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Quality of Life, using the PFIQ-7 The Pelvic Floor Impact Questionnaire assesses how bladder, bowel, and vaginal symptoms affect activity, relationships, ad feelings.\n\nHigher numbers indicate greater disease burden. Score range: 0 to 300', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed surveys at 6 months post treatment.'}, {'type': 'SECONDARY', 'title': 'Pelvic Organ Prolapse Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginal Estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream\n\nVaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}, {'id': 'OG001', 'title': 'Placebo Cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream\n\nPlacebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Pelvic Organ Prolapse Stage, using the POP-Q exam. The Pelvic Organ Prolapse Quantification System use 9 measurements in the vagina to assess prolapse stage.\n\nHigher stage indicates greater prolapse. Range: 0 to 4', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who underwent POP-Q measurements at 6 months post treatment.'}, {'type': 'SECONDARY', 'title': 'Collagenase Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginal Estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream\n\nVaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}, {'id': 'OG001', 'title': 'Placebo Cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream\n\nPlacebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}], 'timeFrame': '6 months', 'description': 'Collagenase Activity, via vaginal swabs collected from the posterior fornix will be used for biochemical analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not available. Vaginal swabs were collected from participants. However, the lab was unable to analyze collagenase activity because there was not enough protein isolated from the samples.'}, {'type': 'SECONDARY', 'title': 'Sexual Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginal Estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream\n\nVaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}, {'id': 'OG001', 'title': 'Placebo Cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream\n\nPlacebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '26'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '23'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Sexual Function, using the PISQ-12 The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire evaluates sexual function in patients with incontinence and/or vaginal prolapse.\n\nHigher scores indicate greater disease burden. Scale: 0 to 48', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed surveys at 6 months post treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaginal Estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream\n\nVaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}, {'id': 'FG001', 'title': 'Placebo Cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream\n\nPlacebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'One subject was ineligible prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vaginal Estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream\n\nVaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}, {'id': 'BG001', 'title': 'Placebo Cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream\n\nPlacebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], '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': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', '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 and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-01', 'size': 183644, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-30T14:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Insufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-13', 'studyFirstSubmitDate': '2012-07-19', 'resultsFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-13', 'studyFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Global Impression of Improvement', 'timeFrame': '6 months after starting vaginal cream', 'description': 'The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians.\n\nPotential Responses:\n\n1. Very Much Better\n2. Much Better\n3. A Little Better\n4. No Change 5, A Little Worse\n\n6\\. Much Worse 7. Very Much Worse Lower scores indicate more imiprovment / better outcome.'}], 'secondaryOutcomes': [{'measure': 'Pelvic Floor Symptoms', 'timeFrame': '6 months', 'description': 'Pelvic Floor Symptoms, using the PFDI-20. The Pelvic Floor Distress Inventory is a condition specific quality of life instrument that assesses distress from pelvic organ prolapse, colorectal-anal, and urinary symptoms.\n\nHigher scores indicate greater disease burden. Range: 0 to 300'}, {'measure': 'General Quality of Life', 'timeFrame': '6 months', 'description': 'Quality of Life, using the PFIQ-7 The Pelvic Floor Impact Questionnaire assesses how bladder, bowel, and vaginal symptoms affect activity, relationships, ad feelings.\n\nHigher numbers indicate greater disease burden. Score range: 0 to 300'}, {'measure': 'Pelvic Organ Prolapse Stage', 'timeFrame': '6 months', 'description': 'Pelvic Organ Prolapse Stage, using the POP-Q exam. The Pelvic Organ Prolapse Quantification System use 9 measurements in the vagina to assess prolapse stage.\n\nHigher stage indicates greater prolapse. Range: 0 to 4'}, {'measure': 'Collagenase Activity', 'timeFrame': '6 months', 'description': 'Collagenase Activity, via vaginal swabs collected from the posterior fornix will be used for biochemical analysis.'}, {'measure': 'Sexual Function', 'timeFrame': '6 months', 'description': 'Sexual Function, using the PISQ-12 The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire evaluates sexual function in patients with incontinence and/or vaginal prolapse.\n\nHigher scores indicate greater disease burden. Scale: 0 to 48'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pelvic organ prolapse', 'Pelvic floor physical therapy', 'Vaginal estrogen', 'Placebo'], 'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.', 'detailedDescription': 'The pathogenesis of pelvic organ prolapse (POP) is unknown. Few studies have correlated patient symptoms and amount of prolapse with biomarkers. POP has traditionally been managed with a pessary or surgery. Recent studies suggest a reduction in POP symptoms following Pelvic Floor Physical Therapy (PFPT). Vaginally delivered hormones are also commonly used to treat prolapse symptoms, with little evidence supporting a clinical benefit. The investigators hypothesize that the optimal approach to improving prolapse symptoms in the patient with mild prolapse requires re-alignment and strengthening of levator muscles via PFPT, and optimization of tissue integrity via local estrogen therapy. The investigators propose to test this hypothesis in a randomized controlled trial in which women with symptomatic mild prolapse opting for PFPT, receive treatment with PFPT in combination with vaginal estrogen versus placebo. The investigators predict that the combined approach will lead to decreased symptoms and improved anatomical support corroborated by biomarker data.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women in good health aged 40-80\n* Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions:\n\nDo you feel or see a vaginal bulge? Do you feel pressure in the vagina?\n\n* Meets POP-Q criteria on exam for stage I, II, or III prolapse\n* Interested in PFPT for management of POP\n* Normal mammogram within 1 year of enrollment\n\nExclusion Criteria:\n\n* Prior surgery for prolapse or incontinence\n* Other prior interventions for prolapse (e.g. pessary, PFPT)\n* Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible)\n* Known liver dysfunction\n* Connective tissue diseases known to affect collagen or elastin remodeling (including: Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome)\n* Unevaluated abnormal vaginal bleeding or abnormal pap smear in the previous year\n* BMI \\> 35 kg/m2\n* Estrogen therapy (including birth control) in the previous year\n* Current or prior breast or pelvic malignancy (ovarian, tubal, uterine, cervical or vaginal)\n* Contraindication to hormone use (i.e. thromboembolic disorder, use of anti-coagulants, coronary artery disease, history of stroke)'}, 'identificationModule': {'nctId': 'NCT01648751', 'briefTitle': 'Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy', 'orgStudyIdInfo': {'id': 'STUDY19030408'}, 'secondaryIdInfos': [{'id': 'R01HD061811', 'link': 'https://reporter.nih.gov/quickSearch/R01HD061811', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaginal estrogen', 'description': 'Patients in the experimental group will receive vaginal estrogen cream', 'interventionNames': ['Drug: Vaginal estrogen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cream', 'description': 'Patients in the comparison group will receive placebo vaginal cream', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vaginal estrogen', 'type': 'DRUG', 'otherNames': ['Premarin vaginal cream'], 'description': '1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter', 'armGroupLabels': ['Vaginal estrogen']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo cream'], 'description': '1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter', 'armGroupLabels': ['Placebo cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital, University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Laura C Skoczylas, MD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Pamela Moalli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamela Moalli', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Urogynecologic Society', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Pamela Moalli', 'investigatorAffiliation': 'University of Pittsburgh'}}}}