Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-10 @ 11:37 PM
Study NCT ID:
NCT00981305
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2009-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D004414', 'term': 'Dyspareunia'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeonmj@snu.ac.kr', 'phone': '82-2-2072-1916', 'title': 'Myung Jae Jeon', 'organization': 'SeoulNUH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Lactate-containing Vaginal Lubricant', 'description': 'apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nLactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)', 'otherNumAtRisk': 50, 'otherNumAffected': 7, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nPlacebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)', 'otherNumAtRisk': 57, 'otherNumAffected': 7, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vaginal itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Both', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Pain Score of Female Sexual Function Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactate-containing Vaginal Lubricant', 'description': 'apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nLactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nPlacebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '1.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of a Total and Other Five Domains of Female Sexual Function Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactate-containing Vaginal Lubricant', 'description': 'apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nLactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nPlacebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '2.85', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '3.81', 'spread': '5.10', 'groupId': 'OG001'}]}]}, {'title': 'Desire', 'categories': [{'measurements': [{'value': '0.19', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Arousal', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Lubrication', 'categories': [{'measurements': [{'value': '0.59', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Orgasm', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of Vaginal pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactate-containing Vaginal Lubricant', 'description': 'apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nLactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nPlacebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of Vaginal Maturation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactate-containing Vaginal Lubricant', 'description': 'apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nLactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nPlacebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.73', 'spread': '10.37', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '8.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).', 'unitOfMeasure': 'vaginal maturation index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lactate-containing Vaginal Lubricant', 'description': 'apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nLactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nPlacebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lactate-containing Vaginal Lubricant', 'description': 'apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nLactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)\n\nPlacebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '49.0', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pregnancies', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '23.3', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '23.2', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Menopause', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tamoxifen treatment', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2009-09-20', 'resultsFirstSubmitDate': '2016-10-09', 'studyFirstSubmitQcDate': '2009-09-21', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-01', 'studyFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Pain Score of Female Sexual Function Index', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.'}], 'secondaryOutcomes': [{'measure': 'Change of a Total and Other Five Domains of Female Sexual Function Index Score', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.'}, {'measure': 'Change of Vaginal pH', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Change of Vaginal Maturation Index', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dyspareunia', 'breast cancer', 'sexual dysfunction', 'vaginal lubricant'], 'conditions': ['Sexual Dysfunction', 'Breast Cancer Survivors']}, 'referencesModule': {'references': [{'pmid': '28383379', 'type': 'DERIVED', 'citation': 'Kim YH, Park S, Lee M, Hahn S, Jeon MJ. Effect of a pH-Balanced Vaginal Gel on Dyspareunia and Sexual Function in Breast Cancer Survivors Who Were Premenopausal at Diagnosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 May;129(5):870-876. doi: 10.1097/AOG.0000000000001988.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.', 'detailedDescription': 'Study scheme\n\n* study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks\n* control arm: placebo apply\n\nOutcome measures\n\n* Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk\n* vaginal maturation index: at 0 wk and 8 wk\n* vaginal pH: at 0 wk and 8 wk'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast cancer survivors over 20 years-old\n* premenopausal at the time of diagnosis\n* treated with operation and chemotherapy\n* newly developed dyspareunia after cancer treatment\n\nExclusion Criteria:\n\n* recent (\\< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)\n* depression or other psychological problems\n* active vaginal infection\n* evidence of cancer recurrence\n* previously use of lactate-containing lubricants\n* other chronic diseases which severely disturb the sexual life'}, 'identificationModule': {'nctId': 'NCT00981305', 'briefTitle': 'Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SNUH 0905-037-281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactate-containing Vaginal Lubricant', 'description': 'apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)', 'interventionNames': ['Drug: Lactate-containing vaginal lubricant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)', 'interventionNames': ['Drug: Placebo vaginal lubricant']}], 'interventions': [{'name': 'Lactate-containing vaginal lubricant', 'type': 'DRUG', 'otherNames': ['Clino-san(commercial name in Korea)'], 'description': 'vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)', 'armGroupLabels': ['Lactate-containing Vaginal Lubricant']}, {'name': 'Placebo vaginal lubricant', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Myung Jae, Jeon', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Myung Jae Jeon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Collaborating Center, Seoul, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}