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

This study has been completed.
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
ViroPan, Inc.
ClinicalTrials.gov Identifier:
NCT02029053
First received: January 3, 2014
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Menopausal and Perimenopausal Disorder, Unspecified
Atrophic Vaginitis
Device: Vaginal Lubrication Ring for Vaginal Dryness
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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

Resource links provided by NLM:


Further study details as provided by ViroPan, Inc.:

Primary Outcome Measures:
  • Vaginal lubrication/moisturization [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted.


Secondary Outcome Measures:
  • Comfort and fit of intravaginal ring [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Assessment of patient satisfaction with the comfort and fit of the intravaginal ring during the study period.


Other Outcome Measures:
  • Successful vaginal placement and removal [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: January 2014
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Names:
  • VR101
  • Intravaginal Ring

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Females over 40 years of age at the time of enrollment
  • Willing to comply with study visit schedule
  • Self-reported peri- or post-menopausal women with self-reported vaginal dryness
  • Willing to abstain from vaginal intercourse while in the study

Exclusion Criteria:

  • Use of hormone therapy
  • Undergoing any vulvar or vaginal procedures (biopsies, radiation in the last 3 months)
  • Active vulvar or vaginal injections/lesions or complaints, as well as undiagnosed abnormal genital bleeding
  • History of chronic pelvic pain, interstitial cystitis, vulvar vestibulitis, pelvic inflammatory disease within the past 12 weeks
  • Known current clinically evident cervical or vaginal infection
  • Postpartum or post-abortion endometritis, unless symptoms resolved at least 12 weeks prior to study entry
  • Current persistent, abnormal vaginal bleeding
  • History of inability to place an IVR
  • History of any abnormality of the vagina resulting in distortion of the vaginal canal or incompatible with IVR placement
  • Body habitus, or history of lower genital tract abnormalities or prior surgeries, which may not allow the vagina to be appropriately accessed
  • Known or suspected allergy or hypersensitivity to polyurethane or glycerol
  • Known current alcohol or illicit drug abuse
  • Participants who have not recovered from adverse events due to chemotherapy or radiation treatment for cancer
  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029053

Locations
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
ViroPan, Inc.
University of Utah
Investigators
Principal Investigator: Margit Janat-Amsbury, MD, PhD University of Utah
  More Information

Publications:
Responsible Party: ViroPan, Inc.
ClinicalTrials.gov Identifier: NCT02029053     History of Changes
Other Study ID Numbers: 67709
Study First Received: January 3, 2014
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ViroPan, Inc.:
Vaginal dryness
Vaginal lubrication
Post-menopausal symptoms
Peri-menopausal symptoms
Urogenital atrophy
Dyspareunia
Painful intercourse

Additional relevant MeSH terms:
Vaginitis
Atrophic Vaginitis
Atrophy
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014