Efficacy of VR101 as a Personal Lubricant

Sexual Dysfunction, Physiological Clinical Trial

Official title: CI03: A Clinical Investigation to Evaluate Efficacy of the J3 Bioscience Lubricating Intravaginal Ring VR101 as a Personal Lubricant Device in Women

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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.

PROCEDURES

Before any study-related tests and procedures are performed all subjects will read, sign, and date the consent document. Information will be collected after the consent document is signed and dated to determine eligibility to enroll in the study. This information includes demographic background, health, medical and social history, birth control method, prescribed medications, herbal or over the-counter drugs, use nonprescription drugs and alcohol. Women who are able to become pregnant will provide a urine sample for a pregnancy test. Potentially eligible subjects will complete the Female Sexual Function Index (FSFI) to assess sexual function in women who are sexually active. If all inclusion and exclusion criteria are satisfied, subjects will be enrolled and randomly assigned to the VR101 Active Ring or Inactive Ring treatment arm of the study.

About 160 female subjects will participate in this study. Upon meeting all inclusion/exclusion criteria, subjects will be randomized (1:1) to one of the two treatment arms and given a 4 week supply of the randomly assigned study devices. They will be instructed on how to use the ring and how to replace the ring weekly. During the 4-week treatment period, subjects will receive weekly phone calls to ensure compliance and collect information about sexual activity, ring replacement, and experience with the device. At the end of four weeks, each subject will return to the study site to complete the final study measures. They will return all unused study devices and undergo a urine sample pregnancy test if appropriate. They will complete the (FSFI) to assess the effects of the study device on sexual function after 4 weeks, and any changes to medications and health will be documented. At that time all subjects will be given the option of receiving an additional 2 weeks of the active VR101 study device. ;

Related Conditions & MeSH terms

• Sexual Dysfunction, Physiological

• NCT number: NCT04288752
• Study type: Interventional
• Source: J3 Bioscience, Inc.
• Status: Completed
• Phase: N/A
• Start date: February 26, 2020
• Completion date: May 26, 2020