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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- Change From Baseline in Total Vaginal Health Index (VHI) Score at 4 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Immediate F-GYN Injection
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.
干预措施: F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel (Device)
Standard Non-Hormonal Care With Delayed F-GYN Injection
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.
干预措施: Standard Non-Hormonal Symptomatic Care (Other)
Standard Non-Hormonal Care With Delayed F-GYN Injection
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.
干预措施: F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel (Device)
结局指标
主要结局
Change From Baseline in Total Vaginal Health Index (VHI) Score at 4 Weeks
时间窗: Baseline and 4 weeks after baseline
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.
次要结局
- 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)
- Change From Pre-Injection in Control Arm Vaginal Dryness, Itching, Burning, and Dyspareunia Scores Assessed by Participant-Reported Numeric Rating Scale(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(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(4 and 12 weeks after F-GYN injection)
- Distribution of Responses to Sponsor-Developed Yes/No Questions on Treatment Satisfaction, Repeat Treatment, and Recommendation(12 weeks after F-GYN injection)
- Number of Participants With Adverse Events and Serious Adverse Events(From baseline through 6 months after F-GYN injection)
- Injection Procedure Tolerability Assessed by Participant-Reported 11-Point Numeric Rating Scale Scores(Immediately after F-GYN injection)
- Number of Participants Who Discontinue the Study for Safety Reasons(From baseline through 6 months after F-GYN injection)
- 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)