Atrophic Vaginitis Clinical Trial
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
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.
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
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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