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Vulvar Atrophy clinical trials

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NCT ID: NCT06333782 Not yet recruiting - Vulvar Atrophy Clinical Trials

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

Start date: March 31, 2024
Phase: N/A
Study type: Interventional

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

NCT ID: NCT00453089 Not yet recruiting - Vaginal Atrophy Clinical Trials

VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women

Start date: June 2012
Phase: Phase 1/Phase 2
Study type: Interventional

To conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical trial in 4 cohorts of 10 postmenopausal women (total N=40) aged 45 to 65 years with at least one menopausal vaginal symptom, vaginal pH > 5.0 and > 20% parabasal vaginal epithelial cells.