Study Comparing Safety and Effectiveness of Genefill Contour and Desirial Plus for Labia Majora Augmentation in Women with Labia Atrophy

What this Trial Is About

This research aims to compare the safety and effectiveness of the Genefill Contour4 hyaluronic acid device with another marketed hyaluronic acid device, Desirial Plus, for labia majora augmentation in women experiencing labia majora hypotrophy or atrophy. The study focuses primarily on assessing the safety of Genefill Contour4 and also evaluates patient symptoms, satisfaction, sexual function, and pain during injection. An additional study within this trial will measure changes in labia volume and distance after treatment. Participants will be randomly assigned to receive injections of either Genefill Contour4 or the comparator Desirial Plus. Injections are given at the first visit, with an optional touch-up at week 4 if needed. The trial lasts for 12 months and involves a total of 8 visits, including screening, five in-person visits, and two phone calls. Both devices are administered similarly, and the study is single-blinded. During the study, participants will be closely monitored through multiple assessments, including the Global Aesthetic Improvement Scale evaluated by both investigators and participants at weeks 4, 12, 24, and 52. Sexual function and patient satisfaction are tracked periodically, along with pain during injections and overall adverse events. The main safety measure is the number of adverse device effects within the first 8 weeks after injection. This comprehensive monitoring continues throughout the 12-month study period to gather detailed safety and effectiveness data.

Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation