A Pivotal Clinical Investigation to Evaluate the Safety and Efficacy of J3 Bioscience Lubricating Intravaginal Ring VR101 in Relieving Symptoms of Vaginal Dryness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Efficacy of VR101 Treatments at 28 Days Assessed by Change in VHI (Vaginal Health Index) Scores Assigned by Clinicians
研究概览
简要总结
This investigation is designed to demonstrate the safety and efficacy of the VR101 lubricating intravaginal ring (IVR) in treating the symptoms of vaginal dryness. In the proposed investigation, participants will use VR101 devices and sham control rings in a crossover study design. All participants who successfully complete the crossover study will be given the option to continue using VR101 for a total of 13 consecutive weeks to evaluate the long-term safety of the new device.
详细描述
CI02, A Pivotal Clinical Investigation to Evaluate the Safety and Efficacy of J3 Bioscience Lubricating Intravaginal Ring VR101 in Relieving Symptoms of Vaginal Dryness, is a multi-center, investigator- and participant-blind, randomized crossover study designed to evaluate the safety and efficacy of VR101 and establish its substantial equivalence to the predicate device, building on the results obtained in CI01, "VR101: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness." The data from CI02 will be used to support a premarket 510(k) notification to the FDA to enable regulatory clearance of the device in the United States (US).
At least 60 participants (up to 69 may be enrolled to account for the anticipated drop-out rate) who consent to be enrolled and meet inclusion/exclusion criteria will be enrolled in the study. To qualify, women must be over the age of 35 who self-report having experienced vaginal dryness symptoms that interfere with daily activities, including but not limited to sexual activity, in the last 60 days; and their clinician-assigned baseline VHI score must be 22 or lower.
Enrolled participants will be randomly assigned to be treated initially by VR101 (GROUP V1S2) or a sham control (GROUP S1V2). Participants randomly assigned to GROUP V1S2 will insert a VR101 device and leave it in place for 7 days, then remove the first device and replace it with a fresh device on day 7. Subsequently, 2 additional devices will be inserted and removed serially on a 7-day schedule until a total of 4 devices are used by each study participant, with the last device removed at day 28.
Participants assigned to S1V2 will insert a sham control ring and leave it in place for 7 days, then remove the first ring and replace it with a new ring on day 7. Subsequently, 2 additional sham rings will be inserted and removed serially on a 7-day schedule until a total of 4 sham rings are used by each study participant, with the last sham ring removed at day 28.
Following completion of the first 28-day treatment course with either VR101 device or sham control, participants will undergo a 21-day "washout" period during which no products (devices or sham rings) will be used, before "crossing over" to treatment with the other product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
VR101 devices and Sham control rings differ only in that VR101 device rings contain glycerol-based lubricant, whereas the Sham controls do not. The product, either VR101 device or Sham ring, is randomly assigned to participants when they are enrolled in the study. Once inserted in the vagina, the devices are indistinguishable. Thus, Investigators cannot tell whether a VR101 device or Sham is in place while performing any vaginal examination. All products (VR101 devices or Sham rings) are intravaginally placed by participants in a room that is not occupied by Care Providers or Investigators, so it is impossible for them to know which product has been assigned. The packaging of all products is identical.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Potential participants must:
- •Completely understand and sign the informed consent form (ability to read and understand the consent form in the English language).
- •Be female 35 years of age or older.
- •Express willingness to comply with the study visit schedule (see Table 4 in study procedures section).
- •Over the course of the study:
- •Express willingness to abstain from the use of any vaginal moisturizers or lubricants or any other topically applied vaginal products not provided by study staff during VR101 or sham use, or during the Washout Period
- •Express willingness to abstain from the use of any HRT (hormone replacement therapy) or hormone-containing birth control products
- •Express willingness to abstain from use of any vaginal ring, diaphragm, cervical cap, or pessary products
- •In the previous 60 days, have self-reported vaginal dryness that interferes with daily activities, which may include sexual intercourse
- •Present with a VHI score of 22 or less, as scored by a trained clinician during the initial visit
排除标准
- •Potential participants self-reporting any of the following will be ineligible for study entry:
- •Current use of HRT (Hormone Replacement Therapy) or any hormone-containing birth control products.
- •Vulvar or vaginal procedures (biopsies, radiation) in the last 3 months
- •Active vulvar or vaginal infections/lesions or complaints, as well as undiagnosed abnormal genital bleeding
- •History of chronic pelvic pain, interstitial cystitis, vulvar vestibulitis, pelvic inflammatory disease within the past 3 months
- •Known current, clinically evident cervical or vaginal infection
- •Participants who have given birth or terminated pregnancy in the past 6 weeks.
- •Postpartum or post-abortion endometritis, unless symptoms resolved at least 3 months prior to study entry
- •Current persistent, abnormal vaginal bleeding
- •History of inability to place a vaginal ring
- •History of any abnormality of the vagina resulting in distortion of the vaginal canal or incompatibility with intravaginal ring placement
- •Body habitus or history of lower genital tract abnormalities or prior surgeries which may not allow the vagina to be appropriately accessed
- •Known or suspected allergy or hypersensitivity to polyurethanes or glycerol
- •Known current alcohol or illicit drug abuse
- •Participants who have not recovered from adverse events due to chemotherapy or radiation treatment for cancer
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the urogenital tract, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Any condition that in the opinion of the investigator or study staff that would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol
- •Current use of a vaginal ring, pessary, cervical cap or diaphragm unless willingness to discontinue for the study duration is expressed
- •Pregnancy or plans to become pregnant in the next 6 months
- •Current breastfeeding and inability or unwillingness to discontinue breastfeeding for the duration of the study
- •NOTE: IUD (Intrauterine Device, e.g., ParaGard®) users may be enrolled provided they commit to exercising caution when removing VR101 as IUD strings have been noted to interfere with VR101 removal.
- •NOTE: Participants who have previously undergone anterior and/or posterior vaginal repair and have received a vaginal mesh implant may have difficulty placing VR101, although no safety issues with VR101 use in CI01 participants who had vaginal mesh implants were noted.
结局指标
主要结局
Efficacy of VR101 Treatments at 28 Days Assessed by Change in VHI (Vaginal Health Index) Scores Assigned by Clinicians
时间窗: Baseline, 28 Days
The Vaginal Health Index (VHI) ranges from 5 to 20 and is calculated via addition of clinician-determined ratings for Vaginal Elasticity, Fluid Volume, Epithelial Integrity, Moisture and pH (each ranges from 1 to 5, with 5 being the best).
Serious Adverse Device Effects
时间窗: Up to 24 weeks total, comprising up to 17 weeks total VR101 use and up to 4 weeks total sham control use.
Number of Participants with Serious Adverse Device Effects Over the VR101 Treatment Period
次要结局
未报告次要终点