F-GYN for Vaginal Dryness and Vulvovaginal Atrophy

NCT07701863 | Not Yet Recruiting

• 1 other identifier: BVC25-005
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Non-Crosslinked Hyaluronic Acid; Intravaginal Injection; Vaginal Dryness; Vulvovaginal Atrophy; Vestibular Atrophy; Dyspareunia; Vaginal Mucosal Hydration

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 weeks after baseline

Secondary Outcomes (12)

• Change From Baseline in Vaginal Dryness, Itching, Burning, and Dyspareunia Scores Assessed by Participant-Reported 11-Point Numeric Rating Scale

  Baseline through 6 months after F-GYN injection

• Change From Baseline in Individual Vaginal Health Index (VHI) Domain Scores

  Baseline, 4 weeks after baseline, and up to 12 weeks after F-GYN injection

• Change From Baseline in Responses to Sponsor-Developed Participant Questionnaire Items on Vaginal Moisture and Sexual Comfort

  Baseline through 6 months after F-GYN injection

• Percentage of Participants With Clinically Meaningful Improvement in Vaginal Dryness or Dyspareunia Assessed by Participant-Reported Numeric Rating Scale

  4 weeks after baseline and through 6 months after F-GYN injection

• Participant-Reported Vaginal Dryness, Itching, Burning, and Dyspareunia Numeric Rating Scale Scores at 2, 4, and 6 Months After F-GYN Injection

  2, 4, and 6 months after F-GYN injection

Study Arms (2)

Immediate F-GYN Injection

EXPERIMENTAL

Participants assigned to this arm will receive a single F-GYN injection at the baseline visit. Follow-up assessments will be performed 4 and 12 weeks after injection, with additional telephone follow-up questionnaires up to 6 months after injection.

Device: F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel

Standard Non-Hormonal Care With Delayed F-GYN Injection

ACTIVE COMPARATOR

Participants assigned to this arm will continue standard non-hormonal symptomatic care for 4 weeks after baseline. After completion of all planned 4-week assessments, participants will receive a single delayed F-GYN injection. Follow-up assessments will then be performed according to the same post-injection schedule as in the immediate injection arm.

Device: F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel; Other: Standard Non-Hormonal Symptomatic Care

Interventions

F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel DEVICE

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.

Immediate F-GYN Injection; Standard Non-Hormonal Care With Delayed F-GYN Injection

Standard Non-Hormonal Symptomatic Care OTHER

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.

Standard Non-Hormonal Care With Delayed F-GYN Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biovico Sp. z o.o.: lead

MeSH Terms

Conditions

Atrophic Vaginitis; Dyspareunia

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07