Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
Study NCT ID:
NCT03782961
Status:
UNKNOWN
Last Update Posted:
2018-12-21
First Post:
2018-12-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Viscosity of a Vaginal Moisturizer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-01-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate subjectively the perceived viscosity change', 'timeFrame': 'Immediately after application, 15 and 30 minutes after application', 'description': 'Perceived viscosity change of the research product from the point of view of the target public under normal conditions of use through a questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Dryness', 'Menopausal Women']}, 'descriptionModule': {'briefSummary': 'To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women', 'detailedDescription': 'A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the research product.\n\nIt will be necessary 33 female research participants, aged between 45 and 70 years menopause with complaint of vaginal dryness.\n\nThe participant will remain in the study for one day, making use of the research product in the Research Center.\n\nParticipants will be divided into 2 groups so that each group observes the viscosity (flow) of the test product in a different anatomical position (lying down and standing) immediately after application of the product, after 15 and 30 minutes.\n\nParticipants will respond to a subjective assessment using a standardized questionnaire to capture possible feelings of discomfort during the study.\n\nA gynecologist will be available to monitor the participants throughout the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Menopausal participants for at least 6 months;\n* Participants with complaints of vaginal dryness;\n* Skin integrity in the region of product analysis;\n* Agreement to comply the procedures of the trial and attend the clinic on the days and times determined for applications and / or evaluations;\n* Understanding, agreement and signing of the Informed Consent Term.\n\nExclusion Criteria:\n\n* Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to selection;\n* Pathologies and / or active skin lesions (local and / or disseminated) in the evaluation area;\n* Immunosuppression by drugs or active diseases;\n* Decompensated endocrinopathies;\n* Relevant clinical history or current evidence of alcohol or other drug abuse;\n* known history or suspected intolerance to products of the same category;\n* Intense sun exposure up to 15 days before evaluation;\n* Gynecological treatment up to 4 weeks before evaluation;\n* Other conditions considered by the researcher to be reasonable for disqualification of study participation.'}, 'identificationModule': {'nctId': 'NCT03782961', 'briefTitle': 'Evaluation of Viscosity of a Vaginal Moisturizer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Farmoquimica S.A.'}, 'officialTitle': 'Evaluation of Perceived Effectiveness to Evaluate Viscosity of a Vaginal Moisturizer in Menopaused Women', 'orgStudyIdInfo': {'id': 'FE4 - HIDRAFEMME - PA - 010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stand up', 'description': 'After application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes', 'interventionNames': ['Device: sodium lactate and combination of polymers']}, {'type': 'EXPERIMENTAL', 'label': 'Lying down', 'description': 'After application of the product (sodium lactate and combination of polymers) remained lying down with the legs stretched for 30 minutes;', 'interventionNames': ['Device: sodium lactate and combination of polymers']}], 'interventions': [{'name': 'sodium lactate and combination of polymers', 'type': 'DEVICE', 'description': 'sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)', 'armGroupLabels': ['Lying down', 'Stand up']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Farmoquimica S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}