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

Inclusion Criteria

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

Exclusion Criteria

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
• 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.