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
Gender: female.
Age: more than 18 years old.
Patient affected by labia majora atrophy/hypotrophy as per investigator's judgement and expressing the wish for volume augmentation of the labia majora.
Patient able to understand and sign the informed consent for study enrolment.
Pregnant or breastfeeding woman or planning a pregnancy during the study
Women who gave birth within 4 months before inclusion.
Patient who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
Patient in a social or sanitary establishment.
Bioscience Cosmetics SL
Lead sponsor
Eurofins
Collaborator