Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-06-07 @ 10:35 PM
Study NCT ID:
NCT02937805
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-29', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture', 'timeFrame': 'Baseline, 5 weeks'}, {'measure': 'Change in vaginal and vulvar pH', 'timeFrame': 'Baseline, 5 weeks'}, {'measure': 'Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist', 'timeFrame': 'Baseline, 5 weeks'}, {'measure': 'Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist', 'timeFrame': 'Baseline, 5 weeks'}, {'measure': 'Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist', 'timeFrame': 'Baseline, 5 weeks'}, {'measure': 'Change in symptoms of vaginal and vulvar atrophy and dryness: symptom questionnaires; scoring from 0 to 3 dryness, burning, itching; VAS evaluation of mucosal dryness, irritation, soreness, pain during exercise, pain during intercourse', 'timeFrame': 'Baseline, 5 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in symptoms of vaginal and vulvar atrophy and dryness: symptom logbooks; daily scoring from 0 to 3 dryness, burning, itching, pain, soreness, symptoms during intercourse', 'timeFrame': 'From baseline to 5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vaginal Dryness', 'Vaginal Atrophy', 'Vulvar Dryness', 'Vulvar Atrophy']}, 'descriptionModule': {'briefSummary': 'Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen. Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of intimate area. The objective of this study is to investigate the effects of a non-hormonal moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of vaginal dryness, burning or itching\n* Symptom severity at least moderate\n\nExclusion Criteria:\n\n* Systemic hormonal replacement therapy during the last 12 months\n* Local hormonal replacement therapy during the last 4 weeks\n* Known allergy to ingredients of the study creams\n* Pregnancy\n* Breast-feeding'}, 'identificationModule': {'nctId': 'NCT02937805', 'briefTitle': 'Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aromtech Ltd.'}, 'orgStudyIdInfo': {'id': 'MCMM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moisturizing vaginal and vulvar sea buckthorn oil cream', 'description': 'Moisturizing non-hormonal vaginal and vulvar cream containing sea buckthorn oil as active ingredient (medical device product in development). Administered twice or once per day for 5 weeks. Post-menopausal women n= 55 + 45. Pre-menopausal women n=15', 'interventionNames': ['Device: Moisturizing vaginal and vulvar sea buckthorn oil cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moisturizing vaginal and vulvar cream', 'description': 'Moisturizing non-hormonal vaginal and vulvar cream (commercial medical device cream already on the market, not containing sea buckthorn oil). Administered once - twice per day for 5 weeks. Postmenopausal women n=55', 'interventionNames': ['Device: Moisturizing vaginal and vulvar cream']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55'}], 'interventions': [{'name': 'Moisturizing vaginal and vulvar sea buckthorn oil cream', 'type': 'DEVICE', 'armGroupLabels': ['Moisturizing vaginal and vulvar sea buckthorn oil cream']}, {'name': 'Moisturizing vaginal and vulvar cream', 'type': 'DEVICE', 'armGroupLabels': ['Moisturizing vaginal and vulvar cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turun Gynekologikeskus', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Risto Erkkola, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turun Gynekologikeskus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Petra Larmo', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Turun Gynekologikeskus Oy', 'class': 'UNKNOWN'}, {'name': 'Tekes - The Finnish Funding Agency for Technology and Innovation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'R&D Manager', 'investigatorFullName': 'Petra Larmo', 'investigatorAffiliation': 'Aromtech Ltd.'}}}}