An interventional study of F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel and Standard Non-Hormonal Symptomatic Care in Atrophic Vaginitis, Atrophic Vulvovaginitis and Vaginal Atrophy, sponsored by Biovico Sp. z o.o.. Recruiting at 3 sites in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Biovico Sp. z o.o. · Not applicable, Interventional, and Treatment
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.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's planned enrollment of 130 is above the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →Biovico Sp. z o.o. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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
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.
Time frame: From baseline through 6 months after F-GYN injection
Started Jul 2026 (actual). Primary completion is estimated for Aug 2027, 13 months after the start.
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