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Efficacy of VR101 as a Personal Lubricant

NCT04288752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2021-08-10

Study results available
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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.

Conditions

  • Sexual Dysfunction, Physiological

Interventions

DEVICE

VR101 Lubricating Intravaginal Ring

VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.

DEVICE

Sham Ring

Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.

Sponsors & Collaborators

  • Advanced Clinical Research Services, LLC

    collaborator OTHER

  • J3 Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Tyler McCabe, PhD · J3 Bioscience, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-26
Primary Completion
2020-05-01
Completion
2020-05-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288752 on ClinicalTrials.gov