Menopausal and Perimenopausal Disorder, UnspecifiedEarly Phase 1NCT02029053
Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness
A Early Phase 1 study testing Vaginal Lubrication Ring for Vaginal Dryness in people with Menopausal and Perimenopausal Disorder, Unspecified and Atrophic Vaginitis, run by J3 Bioscience, Inc. at 1 site in United States.
Trial summary
This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is designed to release glycerol. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Menopausal and Perimenopausal Disorder, Unspecified, Atrophic Vaginitis
- What is being tested?
- Vaginal Lubrication Ring for Vaginal Dryness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Signed informed consent
- Females over 35 years of age at the time of enrollment
- Willing to comply with study visit schedule
- Self-reported peri- or post-menopausal women with self-reported vaginal dryness
- Willing to abstain from vaginal intercourse while in the study
Who cannot join
- Use of hormone therapy
- Undergoing any vulvar or vaginal procedures (biopsies, radiation in the last 3 months)
- Active vulvar or vaginal injections/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 12 weeks
- Known current clinically evident cervical or vaginal infection
- Postpartum or post-abortion endometritis, unless symptoms resolved at least 12 weeks prior to study entry
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- Current persistent, abnormal vaginal bleeding
- History of inability to place an IVR
- History of any abnormality of the vagina resulting in distortion of the vaginal canal or incompatible with IVR 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 polyurethane 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, 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
Official title: VR101: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness
This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is designed to release glycerol. The study will assess the duration of lubrication/ moisturization of the vagina with the VR101 intravaginal ring in place (up to 7 days) and participant satisfaction of the device.
Study participants will insert the intravaginal ring and leave it in place for an initial 7 days and then repeat this process a 2nd time. Participants will respond to questionnaires, complete a daily diary and come in for 4 separate study visits. Each study visit will involve a brief vaginal exam.
Upon removal of the initially inserted device (7 days after first study visit), participants will insert a second device for an additional 7 days and undergo the same evaluation.
Read the detailed description
Vaginal dryness affects many women, although they frequently do not bring up the topic with their doctors. Vaginal dryness can dramatically affect women's lifestyle, in particular their sexual activity and relationship with their partner. Since we believe that living with uncomfortable vaginal dryness does not have to be part of aging, we intend to conduct this study to evaluate a lubricating vaginal ring developed to ease symptoms caused by vaginal dryness.
The objectives of this study are to obtain preliminary data on the ability of the VR101 intravaginal ring to relieve the symptoms of vaginal dryness in peri- and post-menopausal women. Effectiveness will be measured in two ways:
- Vaginal health index scoring assessed by a member of the research team
- Participant answers to questionnaires
Study objectives will assess the following:
- Successful placement of VR101 intravaginal ring into the vagina
- Ease of insertion and removal
- Comfort and fit
- Lubrication/ moisturization of the vagina
- Being tested
- Vaginal Lubrication Ring for Vaginal Dryness
- Keywords
- Vaginal dryness, Vaginal lubrication, Post-menopausal symptoms, Peri-menopausal symptoms, Urogenital atrophy, Dyspareunia, Painful intercourse
- Medical subject headings
- Atrophic Vaginitis, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Lubrication Ring for Vaginal DrynessDevice
Also called VR101, Intravaginal Ring
Participants will be asked to complete 4 study visits and one final follow-up phone call. Each study visit will include a brief vaginal exam where vaginal fluid levels and pH levels are checked and questionnaires are completed. Daily diaries will be completed at home and returned to the study staff at subsequent visits.
Participants will self-insert the Intravaginal ring on the 1st study visit. The 2nd study visit will occur 3-4 days later.
The 3rd study visit will occur approximately 7 days after the 1st visit. Participants will remove the device and self-insert a new intravaginal ring.
The 4th study visit will occur approximately 14 days after the first visit. Participants will remove the intravaginal ring and undergo a final vaginal exam.
Participants will be called approximately 7 days after the last visit and will be asked about their current vaginal dryness symptoms and how they felt about the device during the study.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Other | Vaginal Lubrication Ring for Vaginal Dryness Receives: Device: Vaginal Lubrication Ring for Vaginal Dryness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal lubrication/moisturization
Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted.
Measured: 14 days
Secondary outcomes (1)
Comfort and fit of intravaginal ring
Assessment of patient satisfaction with the comfort and fit of the intravaginal ring during the study period.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Menopausal and Perimenopausal Disorder, UnspecifiedStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- J3 Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Margit Janat-Amsbury, MD, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029053
- Sponsor's protocol ID
- 67709
- Status last verified
- Dec 2015
- First submitted
- 3 Jan 2014
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Palacios S. Managing urogenital atrophy. Maturitas. 2009 Aug 20;63(4):315-8. doi: 10.1016/j.maturitas.2009.04.009. Epub 2009 Jun 2.
PubMed 19493638Vaginal atrophy. Managing vaginal dryness and irritation. Mayo Clin Health Lett. 2012 Oct;30(10):6. No abstract available.
PubMed 23133861Woods NF. An overview of chronic vaginal atrophy and options for symptom management. Nurs Womens Health. 2012 Dec;16(6):482-93; quiz 494. doi: 10.1111/j.1751-486X.2012.01776.x.
PubMed 23253575Andelloux M. Products for sexual lubrication: understanding and addressing options with your patients. Nurs Womens Health. 2011 Jun-Jul;15(3):253-7. doi: 10.1111/j.1751-486X.2011.01642.x. No abstract available.
PubMed 21672177Bond S, Horton LS. Management of postmenopausal vaginal symptoms in women. J Gerontol Nurs. 2010 Jul;36(7):3-7. doi: 10.3928/00989134-20100527-96. Epub 2010 Jul 8.
PubMed 20608584
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR101: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness
- ClinicalTrials.gov ID
- NCT02029053
- Acronym / sponsor ID
- 67709
- Keywords
- Vaginal dryness, Vaginal lubrication, Post-menopausal symptoms, Peri-menopausal symptoms, Urogenital atrophy, Dyspareunia, Painful intercourse
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- J3 Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Utah
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is designed to release glycerol. The study will assess the duration of lubrication/ moisturization of the vagina with the VR101 intravaginal ring in place (up to 7 days) and participant satisfaction of the device.
Study participants will insert the intravaginal ring and leave it in place for an initial 7 days and then repeat this process a 2nd time. Participants will respond to questionnaires, complete a daily diary and come in for 4 separate study visits. Each study visit will involve a brief vaginal exam.
Upon removal of the initially inserted device (7 days after first study visit), participants will insert a second device for an additional 7 days and undergo the same evaluation.
Detailed description
Vaginal dryness affects many women, although they frequently do not bring up the topic with their doctors. Vaginal dryness can dramatically affect women's lifestyle, in particular their sexual activity and relationship with their partner. Since we believe that living with uncomfortable vaginal dryness does not have to be part of aging, we intend to conduct this study to evaluate a lubricating vaginal ring developed to ease symptoms caused by vaginal dryness.
The objectives of this study are to obtain preliminary data on the ability of the VR101 intravaginal ring to relieve the symptoms of vaginal dryness in peri- and post-menopausal women. Effectiveness will be measured in two ways:
- Vaginal health index scoring assessed by a member of the research team
- Participant answers to questionnaires
Study objectives will assess the following:
- Successful placement of VR101 intravaginal ring into the vagina
- Ease of insertion and removal
- Comfort and fit
- Lubrication/ moisturization of the vagina
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Other | Device: Vaginal Lubrication Ring for Vaginal DrynessVaginal Lubrication Ring for Vaginal Dryness |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Females over 35 years of age at the time of enrollment
- Willing to comply with study visit schedule
- Self-reported peri- or post-menopausal women with self-reported vaginal dryness
- Willing to abstain from vaginal intercourse while in the study
Key exclusion criteria (15 listed)
- Use of hormone therapy
- Undergoing any vulvar or vaginal procedures (biopsies, radiation in the last 3 months)
- Active vulvar or vaginal injections/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 12 weeks
- Known current clinically evident 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 |
|---|---|---|
| Vaginal Lubrication Ring for Vaginal DrynessAlso: VR101, Intravaginal RingParticipants will be asked to complete 4 study visits and one final follow-up phone call. Each study visit will include a brief vaginal exam where vaginal fluid levels and pH levels are checked and questionnaires are completed. Daily diaries will be completed at home and returned to the study staff at subsequent visits. Participants will self-insert the Intravaginal ring on the 1st study visit. The 2nd study visit will occur 3-4 days later. The 3rd study visit will occur approximately 7 days after the 1st visit. Participants will remove the device and self-insert a new intravaginal ring. The 4th study visit will occur approximately 14 days after the first visit. Participants will remove the intravaginal ring and undergo a final vaginal exam. Participants will be called approximately 7 days after the last visit and will be asked about their current vaginal dryness symptoms and how they felt about the device during the study. | Device | Single Arm Study |
Primary outcome
Vaginal lubrication/moisturization
Time frame: 14 days
Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted.
1 secondary outcome
Comfort and fit of intravaginal ring
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Background: PubMed 19493638Palacios S. Managing urogenital atrophy. Maturitas. 2009 Aug 20;63(4):315-8. doi: 10.1016/j.maturitas.2009.04.009. Epub 2009 Jun 2.
- Background: PubMed 23133861Vaginal atrophy. Managing vaginal dryness and irritation. Mayo Clin Health Lett. 2012 Oct;30(10):6. No abstract available.
- Background: PubMed 23253575Woods NF. An overview of chronic vaginal atrophy and options for symptom management. Nurs Womens Health. 2012 Dec;16(6):482-93; quiz 494. doi: 10.1111/j.1751-486X.2012.01776.x.
- Background: PubMed 21672177Andelloux M. Products for sexual lubrication: understanding and addressing options with your patients. Nurs Womens Health. 2011 Jun-Jul;15(3):253-7. doi: 10.1111/j.1751-486X.2011.01642.x. No abstract available.
- Background: PubMed 20608584Bond S, Horton LS. Management of postmenopausal vaginal symptoms in women. J Gerontol Nurs. 2010 Jul;36(7):3-7. doi: 10.3928/00989134-20100527-96. Epub 2010 Jul 8.
- Individual participant dataSharing planned: No
Related trials for Menopausal and Perimenopausal Disorder, Unspecified
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A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women
Menopause, Menopausal Hormone Therapy
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.
Margit Janat-Amsbury, MD, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vaginal Lubrication Ring for Vaginal Dryness in people with Menopausal and Perimenopausal Disorder, Unspecified and Atrophic Vaginitis, run by J3 Bioscience, Inc. at 1 site 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 5 inclusion and 15 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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vaginal lubrication/moisturization (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02029053, which also lists 5 linked publications.
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 15 Dec 2015.