Sexual Dysfunction, PhysiologicalNCT04288752
Efficacy of VR101 as a Personal Lubricant
A study testing VR101 Lubricating Intravaginal Ring in people with Sexual Dysfunction, Physiological, run by J3 Bioscience, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Sexual Dysfunction, Physiological
- What is being tested?
- VR101 Lubricating Intravaginal Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2020to 26 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced Clinical Research, Inc. (ACR Idaho)
Meridian, Idaho, 83642
Advanced Clinical Research, Inc. (ACR Utah)
West Jordan, Utah, 84088
About this study
Official title: CI03: A Clinical Investigation to Evaluate Efficacy of the J3 Bioscience Lubricating Intravaginal Ring VR101 as a Personal Lubricant Device in Women
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.
Read the detailed 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.
- Conditions
- Sexual Dysfunction, Physiological
- Being tested
- VR101 Lubricating Intravaginal Ring, Sham Ring
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR101 Lubricating Intravaginal RingDevice
Also called 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.
Sham RingDevice
Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start26 Feb 2020
- Primary completion1 May 2020
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexual Dysfunction, PhysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, sham-controlled, 4-week parallel group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- J3 Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC
- Responsible party
- Sponsor
- Investigators
- Tyler McCabe, PhD, Study director, J3 Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288752
- Sponsor's protocol ID
- CI03
- Status last verified
- Jul 2021
- First submitted
- 25 Feb 2020
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CI03: A Clinical Investigation to Evaluate Efficacy of the J3 Bioscience Lubricating Intravaginal Ring VR101 as a Personal Lubricant Device in Women
- ClinicalTrials.gov ID
- NCT04288752
- Acronym / sponsor ID
- CI03
- Conditions
- Sexual Dysfunction, Physiological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- J3 Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, sham-controlled, 4-week parallel group study
| Arm | Type | Receives |
|---|---|---|
| VR101 Lubricating Intravaginal Ring | Experimental | Device: VR101 Lubricating Intravaginal RingVR101 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. |
| Sham Ring | Sham comparator | Device: Sham RingPerformance 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR101 Lubricating Intravaginal RingAlso: Lubricating intravaginal ringVR101 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 | VR101 Lubricating Intravaginal Ring |
| Sham RingSham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added. | Device | Sham Ring |
Primary outcome
Proportion of Participants With Increased Female Sexual Function Index Lubrication Domain (FSFI-LD) Scores
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler McCabe, PhD study director
J3 Bioscience, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR101 Lubricating Intravaginal Ring in people with Sexual Dysfunction, Physiological, run by J3 Bioscience, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Increased Female Sexual Function Index Lubrication Domain (FSFI-LD) Scores (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.