This clinical study will evaluate the efficacy and safety of F-GYN, a sterile injectable medical device containing non-crosslinked hyaluronic acid, in adult women with moderate to severe vaginal dryness and symptoms related to vaginal and vestibular atrophy.
Vaginal dryness and atrophic changes may cause discomfort, itching, burning, pain during sexual intercourse, reduced lubrication, and lower quality of life. Standard non-hormonal products, such as lubricants and moisturizers, may not provide sufficient relief for all women, and hormonal therapies may be unsuitable or unacceptable for some patients.
Participants will be randomly assigned to one of two groups. Participants in the study group will receive one F-GYN injection at the baseline visit. Participants in the control group will continue standard non-hormonal symptomatic care for 4 weeks and will then receive one F-GYN injection after all planned 4-week assessments have been completed. This allows F-GYN to be compared with standard non-hormonal care during the initial 4-week comparison period.
The injection will be administered by a qualified gynecologist into the vaginal and vestibular tissue. Local anesthesia may be used according to the standard practice of the study site.
The main purpose of the study is to determine whether F-GYN improves vaginal health, assessed by the Vaginal Health Index, after 4 weeks compared with standard non-hormonal symptomatic care without injection. The study will also assess vaginal dryness, itching, burning, pain during sexual intercourse, quality of life, sexual comfort, treatment satisfaction, global improvement, and safety. Participants will attend study visits and will also complete telephone follow-up questionnaires up to 6 months after the injection.
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.
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.