F-GYN for Vaginal Dryness and Vulvovaginal Atrophy

N/ANot Yet RecruitingNCT07701863

Biovico Sp. z o.o.130 enrolled

Overview

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.

This is a prospective, randomized, open-label, multicenter, two-arm clinical study of the F-GYN medical device in adult women with symptoms of vaginal dryness and clinical signs of vaginal and/or vestibular atrophy. Participants will be randomized in a 2:1 ratio to immediate F-GYN injection or to an initial 4-week period of standard non-hormonal symptomatic care followed by delayed F-GYN injection. The initial 4-week period will allow comparison of F-GYN with standard non-hormonal care without injection. After the delayed injection, participants in the control arm will be followed according to the same post-injection schedule as participants receiving immediate injection. The study includes on-site gynecological assessments, participant-reported questionnaires, procedure tolerability assessment, and telephone follow-up. Safety will be monitored throughout the study by collecting adverse events and serious adverse events.

Study Type

Interventions

F-GYN Non-Crosslinked Hyaluronic Acid Injectable GelDEVICE

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.

Standard Non-Hormonal Symptomatic CareOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Clinically significant coagulation disorder. * Known hypersensitivity to any component of the investigational device, local anesthetic, or antiseptic solution. * Current participation or planned participation in another clinical study during participation in the F-GYN study.

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 4 weeks after baseline

Secondary Outcomes

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.

Time frame: Baseline through 6 months after F-GYN injection

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.

Time frame: 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

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.

Time frame: 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

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.

Time frame: 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

Durability of clinical effect after F-GYN injection will be assessed using participant-reported 11-point Numeric Rating Scales collected during telephone follow-up questionnaires. Participants will rate vaginal dryness, itching in the intimate area, burning in the intimate area, and pain during sexual intercourse, or dyspareunia. 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. Each symptom will be summarized separately at each follow-up time point; no composite durability score will be calculated. Participants may choose not to answer the dyspareunia question.

Time frame: 2, 4, and 6 months after F-GYN injection

Change From Pre-Injection in Control Arm Vaginal Dryness, Itching, Burning, and Dyspareunia Scores Assessed by Participant-Reported Numeric Rating Scale

In participants initially assigned to the control arm, changes in symptoms after delayed F-GYN injection will be assessed using participant-reported 11-point Numeric Rating Scales. Participants will rate vaginal dryness, itching in the intimate area, burning in the intimate area, and pain during sexual intercourse, or dyspareunia. 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. Changes will be assessed from the pre-injection visit in the control arm to follow-up visits after delayed F-GYN injection. Each symptom will be summarized separately; no composite symptom score will be calculated. Participants may choose not to answer the dyspareunia question.

Time frame: Pre-injection visit and 4 and 12 weeks after delayed F-GYN injection

Change From Pre-Injection in Control Arm Total Vaginal Health Index (VHI) Score After Delayed F-GYN Injection

In participants initially assigned to the control arm, changes in clinical signs of vaginal and vestibular atrophy after delayed F-GYN injection will be assessed descriptively using the investigator-assessed total Vaginal Health Index (VHI) score. 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. This outcome measure will report the change in total VHI score from the pre-injection visit in the control arm to follow-up visits after delayed F-GYN injection. Individual VHI domain scores are not aggregated separately for this outcome measure.

Time frame: Pre-injection visit and 4 and 12 weeks after delayed F-GYN injection

Distribution of Participant Global Impression of Improvement (PGI-I) Response Categories After F-GYN Injection

Participant global improvement after F-GYN injection will be assessed using the Participant Global Impression of Improvement (PGI-I) scale. The PGI-I is a 7-category participant-reported scale used to assess the participant's overall perception of change after treatment. Response categories range from "very much improved" to "very much worse." More favorable response categories indicate greater perceived improvement. In this study, PGI-I responses will not be numerically coded and no numeric total score will be calculated. Results will be summarized by response category.

Time frame: 4 and 12 weeks after F-GYN injection

Distribution of Responses to Sponsor-Developed Yes/No Questions on Treatment Satisfaction, Repeat Treatment, and Recommendation

Treatment satisfaction and the participant's attitude toward future procedures will be assessed using three sponsor-developed closed yes/no questions completed at the final on-site follow-up visit. The questions assess whether the participant is generally satisfied with the results of the procedure received in the study to improve moisture in the vaginal area, whether the participant would consider continuing or repeating similar procedures in the future to improve moisture in the vaginal area, and whether the participant would recommend such a procedure to another person with similar symptoms based on her experience. Each item has two response options: "yes" or "no." No numeric score or total score will be calculated. Results will be summarized separately for each question as the number and percentage of participants selecting each response category.

Time frame: 12 weeks after F-GYN injection

Number of Participants With Adverse Events and Serious Adverse Events

Safety will be assessed by collecting adverse events (AEs) and serious adverse events (SAEs) throughout the study. The outcome will report the number and percentage of participants with at least one AE and at least one SAE. Events will be summarized by type, severity, seriousness, outcome, and relationship to the investigational device and/or injection procedure, as assessed by the investigator. Events will also be summarized by study period, including the initial non-injection comparison period in the control arm and the period after F-GYN injection.

Time frame: From baseline through 6 months after F-GYN injection

Injection Procedure Tolerability Assessed by Participant-Reported 11-Point Numeric Rating Scale Scores

Tolerability of the F-GYN injection procedure will be assessed immediately after administration using participant-reported 11-point Numeric Rating Scales. Participants will rate pain, stinging, burning, and feeling of pressure at the injection site. Each item is scored separately from 0 to 10, where 0 indicates no pain, stinging, burning, or feeling of pressure, and 10 indicates the worst possible pain, stinging, burning, or feeling of pressure. Higher scores indicate worse procedure tolerability. No composite tolerability score will be calculated.

Time frame: Immediately after F-GYN injection

Number of Participants Who Discontinue the Study for Safety Reasons

Study discontinuations for safety reasons will be assessed throughout the study. This outcome will report the number and percentage of participants who discontinue study participation because of safety-related reasons, including withdrawal due to symptoms related to the investigational device or injection procedure, discontinuation due to an adverse event (AE), or discontinuation due to a serious adverse event (SAE), as assessed by the investigator. Reasons for safety-related discontinuation will be summarized descriptively.