Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-11 @ 12:53 PM
Study NCT ID:
NCT00607295
Status:
COMPLETED
Last Update Posted:
2010-07-27
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Clino-san on Vaginal Dryness of Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-08-11', 'releaseDate': '2011-07-19'}, {'resetDate': '2016-05-24', 'releaseDate': '2016-04-18'}], 'estimatedResultsFirstSubmitDate': '2011-07-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-23', 'studyFirstSubmitDate': '2008-02-04', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vaginal dryness score', 'timeFrame': 'for 12 weeks'}], 'secondaryOutcomes': [{'measure': 'sexual dysfunction', 'timeFrame': 'for 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chemotherapy', 'hormonal therapy', 'urogenital atrophy'], 'conditions': ['Breast Cancer', 'Vaginal Atrophy']}, 'referencesModule': {'references': [{'pmid': '21422866', 'type': 'DERIVED', 'citation': 'Lee YK, Chung HH, Kim JW, Park NH, Song YS, Kang SB. Vaginal pH-balanced gel for the control of atrophic vaginitis among breast cancer survivors: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):922-927. doi: 10.1097/AOG.0b013e3182118790.'}]}, 'descriptionModule': {'briefSummary': '1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life.\n2. "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks.\n3. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast cancer patients\n* who are treated with chemotherapy or hormonal therapy\n* who experience no menstruation after the previous therapy\n* who complain of vaginal dryness\n\nExclusion Criteria:\n\n* other cancer patients\n* other severe disease\n* poor compliance'}, 'identificationModule': {'nctId': 'NCT00607295', 'briefTitle': 'Efficacy and Safety of Clino-san on Vaginal Dryness of Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'SNUH-OG-07-211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Clino-san 2ml vaginal application 3 times per week for 12 weeks', 'interventionNames': ['Drug: clino-san vaginal lubricant']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo 2ml vaginal application 3 times per week for 12 weeks', 'interventionNames': ['Drug: clino-san vaginal lubricant']}], 'interventions': [{'name': 'clino-san vaginal lubricant', 'type': 'DRUG', 'description': 'Clino-san 2ml vaginal application 3 times per week for 12 weeks', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae Weon Kim, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yookyung Lee', 'oldOrganization': 'Seoul National University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-07-19', 'type': 'RELEASE'}, {'date': '2011-08-11', 'type': 'RESET'}, {'date': '2016-04-18', 'type': 'RELEASE'}, {'date': '2016-05-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'YooKyung Lee, MD, Seoul National University Hospital'}}}}