Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness

NCT03150407 | Completed Results FDA Device

• 1 other identifier: CI02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Menopause Related Conditions; Postmenopausal Symptoms

Keywords

vaginal dryness; lubricant; lubrication; intravaginal ring; IVR; vaginal; extended release

Outcome Measures

Primary Outcomes (2)

• Efficacy of VR101 Treatments at 28 Days Assessed by Change in VHI (Vaginal Health Index) Scores Assigned by Clinicians

  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).

  Baseline, 28 Days

• Serious Adverse Device Effects

  Number of Participants with Serious Adverse Device Effects Over the VR101 Treatment Period

  Up to 24 weeks total, comprising up to 17 weeks total VR101 use and up to 4 weeks total sham control use.

Other Outcomes (4)

• Vaginal Dryness Severity Survey (Population Analysis)

  7 Days

• Vaginal Dryness Severity Survey (Individual Analysis)

  7 Days

• VR101 Ease of Use Survey

  First Ring Insertion

Study Arms (3)

VR101 Device

ACTIVE COMPARATOR

Subjects assigned to use randomly-assigned VR101 devices. Each device is to be used for 7 consecutive days, then replaced with a fresh device. Four each VR101 devices will be used. These will be investigated in a cross-over design that will also include consecutive use of 4 Shams, each for 7 days.

Device: VR101 Device (Efficacy)

Sham Control Ring

SHAM COMPARATOR

Subjects assigned to use randomly-assigned Sham rings. Each Sham is to be used for 7 consecutive days, then replaced with a fresh sham. Four each Shams will be used. These will be investigated in a cross-over design that will also include consecutive use of 4 VR101 Devices, each for 7 days.

Other: Sham Control Ring

Long-term Safety Evaluation

OTHER

13-week investigation of the safety of the use of VR101 Devices

Device: VR101 Device (Safety)

Interventions

VR101 Device (Efficacy) DEVICE

Self-insertion of VR101 Device for 7 days, followed by replacement with a fresh VR101Device, until 4 each Devices have been used for 7 days each, with total consecutive device use equal to 28 days

Also known as: VR 101, Device

VR101 Device

Sham Control Ring OTHER

Self-insertion of Sham Ring for 7 days, followed by replacement with a fresh Sham Ring, until 4 each Sham Rings have been used for 7 days each, with total consecutive Sham use equal to 28 days

Also known as: Sham, Sham Ring, Control

Sham Control Ring

VR101 Device (Safety) DEVICE

Following the 4-week use of shams and a 3-week washout period participants randomized to the Safety Study will use a new VR101 device every 7 days for 13 consecutive weeks.

Also known as: VR 101, Device

Long-term Safety Evaluation

Eligibility Criteria

• Age: 35 Years+
• Gender Eligibility Details: Participants must self-identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• J3 Bioscience, Inc.: lead
• Advanced Clinical Research Services, LLC: collaborator
• Phil Triolo and Associates LC: 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

Interventions

Equipment and Supplies; salicylhydroxamic acid

Results Point of Contact

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

tmccabe@j3bio.com

801-550-9956

Study Officials

• Judith Kirstein, MD, CPI

  Advanced Clinical Research Services, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Model Details: 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 or sham control, participants will undergo a 21-day "washout" period during which no devices will be used, before "crossing over" to treatment with the other device.

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 12, 2017
• Study Start: May 1, 2017
• Primary Completion: August 31, 2017
• Study Completion: November 30, 2017
• Last Updated: November 7, 2022
• Results First Posted: November 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)