protocolSection identificationModule nctId: NCT06282614, orgStudyIdInfo id: MUCO245, secondaryIdInfos id: 2023-A02081-44, type: OTHER, domain: ID-RCB, briefTitle: Performance and Safety of MUCOGYNE® Ovule as a Moisturizer, acronym: MOVHYDA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Biocodex, class: INDUSTRY, collaborators name: Voisin Consulting Life Science (VCLS), descriptionModule briefSummary: The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness., conditionsModule conditions: Vaginal Dryness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, multicenter (France), open label without comparator study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Mucogyne Ovule, outcomesModule primaryOutcomes measure: Assessment of the efficacy of MUCOGYNE® Ovule intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use, secondaryOutcomes measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulva irritation, secondaryOutcomes measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort, secondaryOutcomes measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing itching, secondaryOutcomes measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness, secondaryOutcomes measure: Assessment of the patient's sexual function, secondaryOutcomes measure: Assessment of the patient's satisfaction, secondaryOutcomes measure: Assessment of changes in patient's clinical status, secondaryOutcomes measure: Assessment by investigator of changes in patient's clinical status, secondaryOutcomes measure: Assessment of the safety of MUCOGYNE® Ovule, secondaryOutcomes measure: Assessment of the device deficiencies of MUCOGYNE® Ovule, secondaryOutcomes measure: Assessment of the usability of MUCOGYNE® Ovule, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: JEAN Christian's medical office, city: Nogent-sur-Marne, zip: 94130, country: France, geoPoint lat: 48.83333, lon: 2.48333, locations facility: Dr Ramez GHADRI's medical office, city: Orléans, zip: 45100, country: France, contacts name: Ramez GHADRI, MD, role: CONTACT, contacts name: Ramez GHADRI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.90289, lon: 1.90389, locations facility: Dr Raïssa APERANO-MAS's medical office, city: Rennes, zip: 35000, country: France, contacts name: Raïssa APERANO-MAS, MD, role: CONTACT, contacts name: Raïssa APERANO-MAS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.11198, lon: -1.67429, hasResults: False