Menopause Related ConditionsNCT03150407
Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness
A study testing VR101 Device (Efficacy) and VR101 Device (Safety) in people with Menopause Related Conditions and Postmenopausal Symptoms, run by J3 Bioscience, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Menopause Related Conditions, Postmenopausal Symptoms
- What is being tested?
- VR101 Device (Efficacy) and VR101 Device (Safety)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2017to 30 Nov 2017
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 22Show 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 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
- 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 ability to comply with the study protocol
- Current use of a vaginal 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 and inability or unwillingness to discontinue breastfeeding for the duration of the study
- NOTE: IUD (Intrauterine Device, e.g., ParaGard®) 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, although no safety issues with VR101 use in CI01 participants who had vaginal mesh implants were noted.
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: A Pivotal Clinical Investigation to Evaluate the Safety and Efficacy of J3 Bioscience Lubricating Intravaginal Ring VR101 in Relieving Symptoms of Vaginal Dryness
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.
Read the detailed description
CI02, A Pivotal Clinical Investigation to Evaluate the Safety and Efficacy of J3 Bioscience Lubricating Intravaginal Ring VR101 in Relieving Symptoms of Vaginal Dryness, is a multi-center, investigator- and participant-blind, randomized crossover study designed to evaluate the safety and efficacy of VR101 and establish its substantial equivalence to the predicate device, building on the results obtained in CI01, "VR101: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness." The data from CI02 will be used to support a premarket 510(k) notification to the FDA to enable regulatory clearance of the device in the United States (US).
At least 60 participants (up to 69 may be enrolled to account for the anticipated drop-out rate) who consent to be enrolled and meet inclusion/exclusion criteria will be enrolled in the study. To qualify, women must be over the age of 35 who self-report having experienced vaginal dryness symptoms that interfere with daily activities, including but not limited to sexual activity, in the last 60 days; and their clinician-assigned baseline VHI score must be 22 or lower.
Enrolled participants will be randomly assigned to be treated initially by VR101 (GROUP V1S2) or a sham control (GROUP S1V2). 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 device or sham control, participants will undergo a 21-day "washout" period during which no products (devices or sham rings) will be used, before "crossing over" to treatment with the other product.
All participants who successfully complete the crossover study will be given the option to complete the long-term safety evaluation. V1S2 participants who elect to enter the safety study will switch back to VR101 following completion of the crossover study and use a new VR101 device every day for 13 consecutive weeks. S1V2 participants who elect to enter the safety study will continue using a new VR101 device every 7 days for 9 additional weeks, or a total of 13 consecutive weeks.
- Being tested
- VR101 Device (Efficacy), Sham Control Ring, VR101 Device (Safety)
- Keywords
- vaginal dryness, lubricant, lubrication, intravaginal ring, IVR, vaginal, extended release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR101 Device (Efficacy)Device
Also called VR 101, 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
Sham Control RingOther
Also called Sham, Sham Ring, Control
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
VR101 Device (Safety)Device
Also called VR 101, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Control Ring |
| Long-term Safety Evaluation | Other | 13-week investigation of the safety of the use of VR101 Devices Receives: Device: VR101 Device (Safety) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 28 Days
Serious Adverse Device Effects
Number of Participants with Serious Adverse Device Effects Over the VR101 Treatment Period
Measured: Up to 24 weeks total, comprising up to 17 weeks total VR101 use and up to 4 weeks total sham control use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 May 2017
- Primary completion31 Aug 2017
- Study completion30 Nov 2017
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 Menopause Related ConditionsStudies 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
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- J3 Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC, Phil Triolo and Associates LC
- Responsible party
- Sponsor
- Investigators
- Judith Kirstein, MD, CPI, Principal investigator, Advanced Clinical Research Services, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150407
- Sponsor's protocol ID
- CI02
- Status last verified
- Oct 2022
- First submitted
- 8 May 2017
- Last updated
- 7 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no current plan to make individual patient data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Clinical Investigation to Evaluate the Safety and Efficacy of J3 Bioscience Lubricating Intravaginal Ring VR101 in Relieving Symptoms of Vaginal Dryness
- ClinicalTrials.gov ID
- NCT03150407
- Acronym / sponsor ID
- CI02
- Keywords
- vaginal dryness, lubricant, lubrication, intravaginal ring, IVR, vaginal, extended release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- J3 Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC, Phil Triolo and Associates LC
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 7 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CI02, A Pivotal Clinical Investigation to Evaluate the Safety and Efficacy of J3 Bioscience Lubricating Intravaginal Ring VR101 in Relieving Symptoms of Vaginal Dryness, is a multi-center, investigator- and participant-blind, randomized crossover study designed to evaluate the safety and efficacy of VR101 and establish its substantial equivalence to the predicate device, building on the results obtained in CI01, "VR101: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness." The data from CI02 will be used to support a premarket 510(k) notification to the FDA to enable regulatory clearance of the device in the United States (US).
At least 60 participants (up to 69 may be enrolled to account for the anticipated drop-out rate) who consent to be enrolled and meet inclusion/exclusion criteria will be enrolled in the study. To qualify, women must be over the age of 35 who self-report having experienced vaginal dryness symptoms that interfere with daily activities, including but not limited to sexual activity, in the last 60 days; and their clinician-assigned baseline VHI score must be 22 or lower.
Enrolled participants will be randomly assigned to be treated initially by VR101 (GROUP V1S2) or a sham control (GROUP S1V2). 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 device or sham control, participants will undergo a 21-day "washout" period during which no products (devices or sham rings) will be used, before "crossing over" to treatment with the other product.
All participants who successfully complete the crossover study will be given the option to complete the long-term safety evaluation. V1S2 participants who elect to enter the safety study will switch back to VR101 following completion of the crossover study and use a new VR101 device every day for 13 consecutive weeks. S1V2 participants who elect to enter the safety study will continue using a new VR101 device every 7 days for 9 additional weeks, or a total of 13 consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR101 Device | Active comparator | Device: VR101 Device (Efficacy)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. |
| Sham Control Ring | Sham comparator | Other: Sham Control RingSubjects 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. |
| Long-term Safety Evaluation | Other | Device: VR101 Device (Safety)13-week investigation of the safety of the use of VR101 Devices |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- In the previous 60 days, have self-reported vaginal dryness that interferes with daily activities, which may include sexual intercourse
Key exclusion criteria (22 listed)
- 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
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 Device (Efficacy)Also: VR 101, DeviceSelf-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 | Device | VR101 Device |
| Sham Control RingAlso: Sham, Sham Ring, ControlSelf-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 | Other | Sham Control Ring |
| VR101 Device (Safety)Also: VR 101, DeviceFollowing 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. | Device | Long-term Safety Evaluation |
Primary outcome
Efficacy of VR101 Treatments at 28 Days Assessed by Change in VHI (Vaginal Health Index) Scores Assigned by Clinicians
Time frame: Baseline, 28 Days
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).
Serious Adverse Device Effects
Time frame: Up to 24 weeks total, comprising up to 17 weeks total VR101 use and up to 4 weeks total sham control use.
Number of Participants with Serious Adverse Device Effects Over the VR101 Treatment Period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no current plan to make individual patient data available to other researchers.
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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.
Judith Kirstein, MD, CPI principal investigator
Advanced Clinical Research Services, LLC
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 Device (Efficacy) and VR101 Device (Safety) in people with Menopause Related Conditions and Postmenopausal Symptoms, 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 10 inclusion and 22 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 7 Nov 2022. 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 7 Nov 2022). 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?
Efficacy of VR101 Treatments at 28 Days Assessed by Change in VHI (Vaginal Health Index) Scores Assigned by Clinicians (time frame: Baseline, 28 Days). The study lists 2 primary outcomes in all. 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 7 Nov 2022.