NCT02029053

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: J3 Bioscience, Inc. · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

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. 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: 1. Vaginal health index scoring assessed by a member of the research team 2. Participant answers to questionnaires Study objectives will assess the following: 1. Successful placement of VR101 intravaginal ring into the vagina 2. Ease of insertion and removal 3. Comfort and fit 4. Lubrication/ moisturization of the vagina

Conditions

• Menopausal and Perimenopausal Disorder, Unspecified
• Atrophic Vaginitis

Interventions

Type	Name	Description
DEVICE	Vaginal Lubrication Ring for Vaginal Dryness	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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-01-07
• Last updated: 2015-12-15

Locations

1 site across 1 country: United States