Condition: Vulvar Atrophy · Sponsor: Bioscience Cosmetics SL
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
This description comes directly from the study's public registry record.
Dalia Quwaider, PhD, MBA · 0034616711638 · Dalia.quwaider@biosciencegmbh.com
Vanesa Garrido Estevez, PhD · 0034679213437 · Vanesa.garrido@biosciencegmbh.com
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Source record: clinicaltrials.gov/study/NCT06333782