No phaseRecruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Evaluation of the Efficacy and Safety of Intravaginal Injections of the F-GYN Medical Device in Relieving Symptoms of Vaginal Dryness and Improving Signs of Vaginal and Vestibular Atrophy
- Sponsor
- Biovico Sp. z o.o. (Industry)
- Enrolment
- 130 planned
- Conditions
- Atrophic Vaginitis; Atrophic Vulvovaginitis; Vaginal Atrophy; Dyspareunia; Vulvo Vaginal Atrophy; Vaginal Dryness
- Interventions
- F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel; Standard Non-Hormonal Symptomatic Care
- Ages
- adults, older adults
- Registry
- NCT07701863
From the registry
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…
Primary outcomes
- Change From Baseline in Total Vaginal Health Index (VHI) Score at 4 Weeks