Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness
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.
|Menopausal and Perimenopausal Disorder, Unspecified Atrophic Vaginitis||Device: Vaginal Lubrication Ring for Vaginal Dryness||Early Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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|
- Vaginal lubrication/moisturization [ Time Frame: 14 days ]Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted.
- 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.
- 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.
|Study Start Date:||January 2014|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Single Arm Study
Vaginal Lubrication Ring for Vaginal Dryness
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02029053
|United States, Utah|
|University of Utah Health Sciences Center|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Margit Janat-Amsbury, MD, PhD||University of Utah|