Efficacy of VR101 as a Personal Lubricant

NCT04288752 | Completed Results FDA Device

• 1 other identifier: CI03
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Increased Female Sexual Function Index Lubrication Domain (FSFI-LD) Scores

  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.

  4 weeks

Study Arms (2)

VR101 Lubricating Intravaginal Ring

EXPERIMENTAL

VR101 is a clear, flexible, torus-shaped lubricating intravaginal ring (IVR) manufactured from hollow tubing formed from Excipient Grade Thermoplastic Urethane Pathway® Polymer PY-PT42DE35 by hot-melt extrusion. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up.

Device: VR101 Lubricating Intravaginal Ring

Sham Ring

SHAM COMPARATOR

Performance of VR101 will be compared to that of an inactive ring. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up. Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.

Device: Sham Ring

Interventions

VR101 Lubricating Intravaginal Ring DEVICE

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.

Also known as: Lubricating intravaginal ring

VR101 Lubricating Intravaginal Ring

Sham Ring DEVICE

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

Sham Ring

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 3.
• Attempt sexual intercourse at least 4 times during the 4-week double-blind study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• J3 Bioscience, Inc.: lead
• Advanced Clinical Research Services, LLC: collaborator

Study Sites (2)

Advanced Clinical Research, Inc. (ACR Idaho)

Meridian, Idaho, 83642, United States

Location

Advanced Clinical Research, Inc. (ACR Utah)

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: R. Tyler McCabe, Ph.D.
• Organization: J3 Bioscience, Inc

tmccabe@j3bio.com

801-550-9956

Study Officials

• Tyler McCabe, PhD

  J3 Bioscience, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, sham-controlled, 4-week parallel group study

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: February 26, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 26, 2020
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)