protocolSection identificationModule nctId: NCT06333782, orgStudyIdInfo id: 2023-EU-GEN-01, secondaryIdInfos id: 2023-A02012-43, type: OTHER, domain: ANSM, briefTitle: Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Bioscience Cosmetics SL, class: INDUSTRY, collaborators name: Eurofins, descriptionModule briefSummary: The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy.The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection).Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group.An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection, conditionsModule conditions: Vulvar Atrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants would be randomized on two groups: Genefill Contour or comparator (Desirial Plus) at a ratio 1:1, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Single blind, whoMasked: PARTICIPANT, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Experimental- Genefill Contour®, interventions name: Marketed comparator - Desirial®Plus, outcomesModule primaryOutcomes measure: Mean of number of occurred ADEs (Adverse device effects), secondaryOutcomes measure: Global Aesthetic Improvement Scale (GAIS) assessment by investigator, secondaryOutcomes measure: Global Aesthetic Improvement Scale (GAIS) assessment by participant, secondaryOutcomes measure: Patient (Atrophy/Hypotrophy) symptoms, secondaryOutcomes measure: Sexual function Assessment, The Female Sexual Function Index (FSFI), secondaryOutcomes measure: Patient´s satisfaction, secondaryOutcomes measure: Pain during injection-Visual Analogical Scale (VAS), secondaryOutcomes measure: Adverse Events collection (Global safety during the study period), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cabinet renaissance, city: Levallois-Perret, state: Paris, zip: 92300, country: France, contacts name: Massimo Gianfermi, MD, role: CONTACT, geoPoint lat: 48.89389, lon: 2.28864, locations facility: Palais Flore, city: Lyon, zip: 69006, country: France, contacts name: Johanna Gratadour, MD, role: CONTACT, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Medical Center "Tu sie leczy", city: Gdańsk, state: Gdansk, country: Poland, contacts name: Katarzyna Kopacz-Petranyuk, MD, role: CONTACT, geoPoint lat: 54.35205, lon: 18.64637, hasResults: False