F-GYN for Vaginal Dryness and Vulvovaginal Atrophy (F-GYN)

Inclusion Criteria:

• Female participants.
• Age over 18 years.
• Decreased moisture of the vaginal and/or vestibular mucosa confirmed by the investigator during gynecological examination, defined as a moisture/fluid volume domain score of 3 or less on a 5-point scale.
• Participant-reported vaginal dryness and/or pain during sexual intercourse with a score of at least 5 on an 11-point numeric rating scale at the baseline visit.
• Willingness not to use intravaginal or systemic hormonal therapies for the treatment of vaginal dryness or vaginal atrophy during the study. Stable hormonal contraception without planned changes during the study is allowed.
• Willingness to report all medications, intravaginal products, vaginal gels, creams, suppositories, lubricants, and other products used to relieve symptoms of vaginal dryness during the study.
• Ability and willingness to provide voluntary written informed consent before any study-related procedures.
• For participants of childbearing potential: negative urine pregnancy test at the baseline visit and, for participants assigned to the control arm, also before F-GYN injection; willingness to use a method of contraception accepted by the investigator throughout the study.

Exclusion Criteria:

• Menstruation or genital tract bleeding of unknown cause on the day of the screening/baseline visit.
• Pregnancy, breastfeeding, or planned pregnancy during the study.
• Presence of varices, open wounds, ulcers, active infections, or other clinically significant damage of the vaginal or vestibular mucosa at the planned injection sites.
• Tendency to develop hypertrophic scars or keloids.
• Active vaginal or vulvar infection, including viral, bacterial, or fungal infection.
• Active urinary tract infection.
• Other genital tract conditions that, in the investigator's opinion, could affect assessment of study outcomes.
• Severe disease or other medical condition that, in the investigator's opinion, could affect assessment of study outcomes or participant safety.
• Local treatment in the study area within 4 weeks before the baseline visit that could significantly affect study outcomes, including intravaginal hormonal products such as suppositories, creams, or vaginal tablets.
• Use of intravaginal products containing hyaluronic acid or other substances with a potentially long-lasting effect on vaginal mucosal atrophy within 4 weeks before the baseline visit.
• Systemic hormonal therapy or estrogen receptor modulation, such as selective estrogen receptor modulators, that could affect the vaginal mucosa within 8 weeks before the baseline visit.
• Anti-estrogen therapy, including tamoxifen or aromatase inhibitors, for hormone-dependent breast cancer within 12 months before the baseline visit.
• Injection procedures at the planned injection sites, such as hyaluronic acid, platelet-rich plasma, or other injectable therapies, within 6 months before the start of the study.
• Device-based procedures with potential effects on vaginal mucosal atrophy at the planned treatment area, such as CO₂ laser, radiofrequency, or similar procedures, within 6 months before the start of the study.
• Use of anticoagulant or antiplatelet medication.
• Clinically significant coagulation disorder.
• Known hypersensitivity to any component of the investigational device, local anesthetic, or antiseptic solution.
• Current participation or planned participation in another clinical study during participation in the F-GYN study.