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Clinical Trial

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

NCT: NCT06333782 · COMPLETED

NCT IDNCT06333782
StatusCOMPLETED
Start Date2024-05-13
Completion2026-04-03
SponsorBioscience Cosmetics SL (INDUSTRY)
First posted
Last updated

Brief Summary

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

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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