Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT00803335
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2008-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D059268', 'term': 'Atrophic Vaginitis'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal 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'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-25', 'studyFirstSubmitDate': '2008-12-04', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains.', 'timeFrame': 'baseline and 2-12 weeks after treatment (at time of surgery)'}], 'secondaryOutcomes': [{'measure': 'Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.', 'timeFrame': 'baseline and 2-12 weeks after treatment (at time of surgery)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pelvic organ prolapse', 'vaginal atrophy', 'atrophic vaginitis', 'postmenopausal', 'posthysterectomy', 'vaginal health', 'vaginal cytology', 'vaginal maturity index', 'vaginal histology', 'quality of life questionnaires'], 'conditions': ['Pelvic Organ Prolapse', 'Vaginal Atrophy']}, 'referencesModule': {'references': [{'pmid': '37431855', 'type': 'DERIVED', 'citation': 'Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.', 'detailedDescription': 'Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 45 years or older\n* Postmenopausal (\\>55 if natural menopause)\n* Clinical atrophic vaginitis (at least mild atrophy)\n* Pelvic organ prolapse(at least stage 2 or greater)\n* Posthysterectomy\n* Surgery date between 2-12 weeks after recruitment\n\nExclusion Criteria:\n\n* Uterus present\n* Well-estrogenized appearing vagina\n* Known or suspected history of breast carcinoma\n* Hormone-dependent tumor\n* Genital bleeding of unknown cause\n* Acute thrombophlebitis or thromboembolic disorder associated with estrogen use\n* Vaginal infection requiring treatment\n* Allergy to estrogen or its constituents\n* Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance.\n* Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment\n* Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)'}, 'identificationModule': {'nctId': 'NCT00803335', 'briefTitle': 'The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial', 'orgStudyIdInfo': {'id': '08135-08-076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Premarin cream 0.5gm', 'description': 'Application of 0.5gm of vaginal estrogen cream nightly until surgery.', 'interventionNames': ['Drug: Vaginal conjugated estrogen cream 0.5gm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Premarin cream 1.0gm', 'description': 'Application of 1.0gm of vaginal estrogen cream nightly until surgery.', 'interventionNames': ['Drug: Vaginal conjugated estrogen cream 1.0gm']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention.'}], 'interventions': [{'name': 'Vaginal conjugated estrogen cream 0.5gm', 'type': 'DRUG', 'otherNames': ['Premarin'], 'description': 'Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.', 'armGroupLabels': ['Premarin cream 0.5gm']}, {'name': 'Vaginal conjugated estrogen cream 1.0gm', 'type': 'DRUG', 'otherNames': ['Premarin'], 'description': 'Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.', 'armGroupLabels': ['Premarin cream 1.0gm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Trihealth (Good Samaritan Hospital, Bethesda North Hospital)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Christine M Vaccaro, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Good Samaritan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}