The Dermal Filler is recommended for the female intimate areas, especially the internal area of the vagina (vaginal vestibule, introitus, vaginal walls, clitoris, G spot) for the following indications: vaginal dryness or discomfort, vaginal atrophy.~The main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.~The MMG-23-04-2019 is contained in pre-filled, graduated and disposable sterile syringe with Luer Lock adapter with 1 ml of net content and 20 mg/ml hyaluronic acid.~The MMG-23-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device.
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler MMG-23-04-2019 on the female genital area for the medicinal, functional and reconstructive indications.