Vaginal Dryness Ring - VR101 Pilot Study

Overview

Status: Completed
Keywords: Vaginal dryness , Vaginal moisturization , Post-menopausal symptoms , Peri-menopausal symptoms
IRB Number: 00067709
Specialty: OB/Gyn, General
Sub Specialties:

Brief Summary

STUDY DESIGN

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.

Study Objectives

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)
Co Investigator:

Contact Information

Name:Vera Wuensche
Phone: 801-587-0975
Email: vera.wuensche@hsc.utah.edu

Inclusion Criteria

  1. Signed informed consent
  2. Females over 35 years of age at the time of enrollment
  3. Willing to comply with study visit schedule (see Table 1 in study procedures section)
  4. Self-reported peri- or post-menopausal women with self-reported vaginal dryness
  5. Willing to abstain from vaginal intercourse while in the study

 

Exclusion Criteria

Participants meeting any of the following self-reported criteria will be ineligible for study entry

  1. Use of hormone therapy
  2. Undergoing any vulvar or vaginal procedures (biopsies, radiation in the last 3 months)
  3. Active vulvar or vaginal injections/lesions or complaints, as well as undiagnosed abnormal genital bleeding
  4. History of chronic pelvic pain, interstitial cystitis, vulvar vestibulitis, pelvic inflammatory disease within the past 12 weeks
  5. Known current clinically evident cervical or vaginal infection
  6. Postpartum or post-abortion endometritis, unless symptoms resolved at least 12 weeks prior to study entry
  7. Current persistent, abnormal vaginal bleeding
  8. History of inability to place an IVR
  9. History of any abnormality of the vagina resulting in distortion of the vaginal canal or incompatible with IVR placement
  10. Body habitus, or history of lower genital tract abnormalities or prior surgeries, which may not allow the vagina to be appropriately accessed
  11. Known or suspected allergy or hypersensitivity to polyurethane or glycerol
  12. Known current alcohol or illicit drug abuse
  13. Participants who have not recovered from adverse events due to chemotherapy or radiation treatment for cancer
  14. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  15. Any condition that, in the opinion of the investigator or study staff that would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol