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

Completed · Early Phase 1

Conditions studied: Menopausal and Perimenopausal Disorder, Unspecified, Atrophic Vaginitis

In brief

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.

Key facts

Study ID

NCT02029053

Run by

J3 Bioscience, Inc.

People needed

21

Starts

2014-01-01

Expected to finish

2014-05-01

Last updated by the study team

2015-12-15

Who can join

Age: 35 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Utah Health Sciences Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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