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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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

Sponsor: J3 Bioscience, Inc.

Current Primary Outcome: Vaginal lubrication/moisturization [ Time Frame: 14 days ]

Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted.


Original Primary Outcome: Successful vaginal placement and removal [ Time Frame: 14 days ]

Assessment of patient ability to self-insert and self-remove the intravaginal ring at the initial study visit as well as throughout the 14 day time period of the study.


Current Secondary Outcome: Comfort and fit of intravaginal ring [ Time Frame: 14 days ]

Assessment of patient satisfaction with the comfort and fit of the intravaginal ring during the study period.


Original Secondary Outcome: Same as current

Information By: J3 Bioscience, Inc.

Dates:
Date Received: January 3, 2014
Date Started: January 2014
Date Completion:
Last Updated: December 14, 2015
Last Verified: December 2015