Clinical trials

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Condition / disease
Location
Status: Recruiting

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

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

Participants needed: 110
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Bioscience Cosmetics SLUpdated: Aug 9, 2024Locations: 3
Eligibility criteria

Gender: female. [+6]

Pregnant or breastfeeding woman or planning a pregnancy during the study [+28]