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.
Parallel
F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel
DeviceF-GYN is a sterile, single-use injectable medical device containing 2.2% non-crosslinked high-molecular-weight hyaluronic acid gel in a 2 mL prefilled syringe. The device is administered as a single intravaginal injection by a qualified gynecologist. The gel is injected into the superficial submucosal or intramucosal layer of the vaginal and vestibular tissue, including the area around the vaginal opening and the distal posterior and lateral vaginal walls. The total injected volume is up to 2 mL. Local anesthesia and standard antiseptic preparation may be used according to the standard practice of the study site.
Standard Non-Hormonal Symptomatic Care
Other interventionParticipants assigned to the control arm may continue their previously used standard non-hormonal products intended to relieve vaginal dryness or improve lubrication during sexual intercourse, such as vaginal moisturizers, gels, creams, suppositories, or lubricants. These products must not contain hormones, hyaluronic acid, or other ingredients with a potentially long-lasting effect on vaginal mucosal atrophy. The type, trade name, and frequency of use will be recorded in the participant diary and clinical case report form. Any change in product use requires investigator approval.
Change From Baseline in Total Vaginal Health Index (VHI) Score at 4 Weeks
The total Vaginal Health Index (VHI) score will be assessed by the investigator during gynecological examination. The VHI includes five domains: vaginal elasticity, vaginal fluid volume, vaginal pH, epithelial integrity, and vaginal moisture. Each domain is scored from 1 to 5, and the total VHI score is calculated as the sum of the five domain scores, ranging from 5 to 25. Higher scores indicate better vaginal health and fewer clinical signs of vaginal atrophy. The change from baseline in total VHI score will be compared between the immediate F-GYN injection arm and the control arm receiving standard non-hormonal symptomatic care without injection during the initial 4-week comparison period.
Change From Baseline in Vaginal Dryness, Itching, Burning, and Dyspareunia Scores Assessed by Participant-Reported 11-Point Numeric Rating Scale
Vaginal dryness, itching in the intimate area, burning in the intimate area, and pain during sexual intercourse, or dyspareunia, will be assessed using participant-reported 11-point Numeric Rating Scales. Each symptom score ranges from 0 to 10. For vaginal dryness, 0 indicates a very moisturized vagina and 10 indicates a very dry vagina. For itching, burning, and dyspareunia, 0 indicates no symptom and 10 indicates a very severe symptom. Higher scores indicate worse symptoms. Participants may choose not to answer the dyspareunia question. The same symptom items and scoring method will be used during on-site visits and telephone follow-up assessments.
Change From Baseline in Individual Vaginal Health Index (VHI) Domain Scores
Individual domains of the Vaginal Health Index (VHI) will be assessed by the investigator during gynecological examination. The VHI includes five domains: vaginal elasticity, vaginal fluid volume, vaginal pH, epithelial integrity, and vaginal moisture. Each individual domain score ranges from 1 to 5. A score of 1 indicates the poorest clinical finding for that domain, and a score of 5 indicates the best clinical finding for that domain. Higher scores indicate better vaginal health and fewer clinical signs of vaginal atrophy. Changes from baseline will be analyzed for each VHI domain separately.
Change From Baseline in Responses to Sponsor-Developed Participant Questionnaire Items on Vaginal Moisture and Sexual Comfort
Participant-reported quality of life and sexual comfort related to vaginal moisture will be assessed using sponsor-developed participant questionnaire items. The items assess satisfaction with vaginal moisture, attractiveness and self-confidence related to vaginal moisture, comfort during physical activity, vaginal moisture during sexual activity, pleasure during sexual intercourse, and willingness to have sexual intercourse. Each item has ordered categorical response options: very dissatisfied, somewhat dissatisfied, somewhat satisfied, and very satisfied. More favorable response categories indicate greater satisfaction or better comfort. Participants may choose "I do not want to answer" for sensitive questions. No numeric total score will be calculated for these items.
Percentage of Participants With Clinically Meaningful Improvement in Vaginal Dryness or Dyspareunia Assessed by Participant-Reported Numeric Rating Scale
Clinically meaningful improvement will be defined as an improvement of at least 3 points in vaginal dryness score and/or reduction of pain during sexual intercourse, or dyspareunia, to a score of 0 to 2. Vaginal dryness and dyspareunia will be assessed using participant-reported 11-point Numeric Rating Scales. For vaginal dryness, the score ranges from 0 to 10, where 0 indicates a very moisturized vagina and 10 indicates a very dry vagina. For dyspareunia, the score ranges from 0 to 10, where 0 indicates no pain and 10 indicates very severe pain. Higher scores indicate worse symptoms. Participants may choose not to answer the dyspareunia question.
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