Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness

Study Overview
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Brief Summary
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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
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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

Official Title
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VR101: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness

Conditions
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Menopausal and Perimenopausal Disorder, Unspecified, Atrophic Vaginitis

Intervention / Treatment
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* Device: Vaginal Lubrication Ring for Vaginal Dryness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm Study<br>Vaginal Lubrication Ring for Vaginal Dryness | Device: Vaginal Lubrication Ring for Vaginal Dryness<br>* 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.<br>* Other names: Intravaginal Ring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal lubrication/moisturization | Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort and fit of intravaginal ring | Assessment of patient satisfaction with the comfort and fit of the intravaginal ring during the study period. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal dryness, Vaginal lubrication, Post-menopausal symptoms, Peri-menopausal symptoms, Urogenital atrophy, Dyspareunia, Painful intercourse