The proposed clinical study is a pilot, open-label, single-center study to preliminarily study the feasibility and safety of the use of VR101 to relieve the symptoms of vaginal dryness. In addition, the study will assess the duration of action of VR101 (up to 7 days) and user acceptability of the device. Twenty (20) female participants 40+ years of age who meet the eligibility requirements and consent to be in the study will insert VR101 according to the instructions provided in the investigational protocol (it is anticipated that approximately 30 female participants may be consented to enroll in the study to have 20 participants complete the entire study duration). Study participants will insert VR101 for 7 days and submit to study assessments and respond to a questionnaire. Upon removal of the initially inserted device, study participants will insert a second device for an additional 7 days and undergo the same evaluation. The total exposure of VR101 is up to 14 days for this pilot study.
The objectives of this study are to obtain preliminary data on the ability of the VR101 to relieve the symptoms of vaginal dryness in post- and perimenopausal women. Effectiveness will be measured by means of self-reported questionnaires and vaginal health index scoring (Rohan et al., 2000) will be assessed by a member of the research team. Assessments consist of the following:
- Successful placement of VR101 into the vagina
- Ease of insertion and removal
- Comfort and fit
- Lubrication/ moisturization of the vagina
Principal Investigator: Margit-Maria Janat-Amsbury
Department: Obstetrics/Gynecology OP (Div)