F-GYN for Vaginal Dryness and Vulvovaginal Atrophy

Summary

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.

Conditions

• Atrophic Vaginitis
• Atrophic Vulvovaginitis
• Vaginal Atrophy
• Dyspareunia
• Vulvo Vaginal Atrophy
• Vaginal Dryness

Interventions

DEVICE

F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel

F-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.

OTHER

Standard Non-Hormonal Symptomatic Care

Participants 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.

Sponsors & Collaborators

• Biovico Sp. z o.o.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2027-08-31

Completion

2027-08-31