CI03: A Clinical Investigation to Evaluate Efficacy of the J3 Bioscience Lubricating Intravaginal Ring VR101 as a Personal Lubricant Device in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 4
- 主要终点
- Proportion of Participants With Increased Female Sexual Function Index Lubrication Domain (FSFI-LD) Scores
研究概览
简要总结
This Clinical Investigation (CI03) is designed to validate the efficacy of the VR101 lubricating Intravaginal Ring (IVR) as a personal lubricant device. In the proposed clinical investigation, participants will be randomized into two groups for the study, VR101 Active Ring and Inactive Ring. Participants will use VR101 active rings or inactive rings for 28 days in a randomized, double-blind, parallel group design. The study also includes an optional two-week open-label extension with active rings, and a one-week follow-up.
详细描述
BACKGROUND This study will look at the use of a study device that is intended to provide moisture and lubrication to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. To date, regarding human clinical testing, the study device has been tested and evaluated in a human study with 72 female subjects and another study with 21 female subjects.
The purpose of this research study is to assess how safe and effective the study device (a vaginal ring referred to as VR101) is at providing personal lubrication. The study will compare the effectiveness of VR101 active ring compared to VR101 inactive ring, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This is a research study to test a new investigational device. An investigational device is one that is not approved by the United States Food and Drug Administration (FDA). The study device is in the form of a clear, flexible ring that is placed in the vagina. Each ring is about 2 inches in diameter, or across the ring, from one side to the other.
During the study, participants will receive either the VR101 active ring or a ring that looks exactly like the VR101 ring but is inactive. For the purposes of this document, both VR101 active ring and the inactive ring will be referred to as the study ring, or study device.
Because this is a research study, study rings will be given to participants only during this study and must only be used according to the schedule that will be described by study staff. Participants will not be allowed to use them once the study is complete.
The results will be reported in a submission to the FDA to determine if the VR101 study device can be legally marketed in the United States.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The trial will be double-blind, meaning the subject and Investigator/staff will not have access to or knowledge of the subject's treatment assignment. Further, since the Sponsor will securely maintain the randomization schedules, the Sponsor and Sponsor's representatives will not be made aware of a given subject's randomization arm until the blind is broken. The Sponsor will ensure that the Study Monitor does not ever have access to the randomization assignments.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical Investigation Participants Must:
- •Completely understand and sign the informed consent form (ability to read and understand the consent form in the English language).
- •Be at least 21 years of age.
- •Express a willingness to comply with the entire study visit schedule outlined in the protocol.
- •Over the course of the study:
- •Abstain from the use of any vaginal moisturizers or lubricants or any other topically applied vaginal products not provided by study staff during the entirety of study participation
- •Abstain from using lubricated or spermicide-containing male or female condoms
- •Abstain from vaginal intercourse with a male partner using a lubricated condom
- •Abstain from any oral sex during or prior to vaginal intercourse with a male partner.
- •Must not initiate, modify or discontinue a regimen of HRT (hormone replacement therapy) or estrogen-containing birth control.
- •NOTE: Women who have been using non-vaginal HRT or estrogen-containing birth control (e.g., oral, transdermal) on a regular dosing interval continuously for at least 3 months may continue on the same regimen during the study
- •Abstain from the use of any other vaginally-placed devices (e.g. ring, diaphragm, cervical cap, pessary products)
- •If able to get pregnant, use an approved method of contraception (per the remainder of I/E criteria) to reduce their risk of becoming pregnant during the study.
- •In the previous 3 months, have had or attempted sexual intercourse with a male partner a minimum of twice per month (on average).
- •Respond to all 4 individual FSFI Lubrication Questions (7 - 10) with a score of 1, 2, or
- •Attempt sexual intercourse at least 4 times during the 4-week double-blind study.
排除标准
- •for participant selection
- •Participants self-reporting any of the following will be ineligible for study entry:
- •Current use of HRT (Hormone Replacement Therapy) or any estrogen-containing birth control products, unless not applied vaginally and the participant has been on a regular dosing interval for at least 3 months prior and is willing to continue the same regimen without modification throughout study participation.
- •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 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 the inability to place a vaginal ring.
- •History of any abnormality of the vagina resulting in distortion of the vaginal canal or incompatibility with vaginal 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 the ability to comply with the study protocol.
- •Current use of a vaginally-placed device (e.g., 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.
- •Participation in a previous ViroPan or J3 Bioscience clinical trial for VR101 (i.e., CI01, CI02)
- •NOTE: IUD (Intrauterine Device) 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 but are not automatically excluded from the study.
结局指标
主要结局
Proportion of Participants With Increased Female Sexual Function Index Lubrication Domain (FSFI-LD) Scores
时间窗: 4 weeks
The Female Sexual Function Index (FSFI) is a survey validated to assess sexual function in women. The FSFI contains 19 questions, divided in to 6 characteristic domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Although all of these characteristics may be improved by use of a personal lubricant, only the Lubrication Domain (FSFI-LD) is directly relevant to a lubricant's intended use. Primary Endpoint: Proportion of participants that experience increased vaginal lubrication that enhances ease and comfort of intimate sexual activity, defined as an FSFI-LD ≥ 4.5 (out of 6.0) with 4 consecutive weeks of weekly ring use.
次要结局
未报告次要终点