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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029053
• Other study ID #: 67709
• Status: Completed
• Phase: Phase 0
• First received: January 3, 2014
• Last updated: December 14, 2015
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: December 2015
• Source: ViroPan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Females over 35 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Menopausal and Perimenopausal Disorder, Unspecified

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
ViroPan, Inc.	University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (5)

Andelloux M. Products for sexual lubrication: understanding and addressing options with your patients. Nurs Womens Health. 2011 Jun-Jul;15(3):253-7. doi: 10.1111/j.1751-486X.2011.01642.x. — View Citation

Bond S, Horton LS. Management of postmenopausal vaginal symptoms in women. J Gerontol Nurs. 2010 Jul;36(7):3-7. doi: 10.3928/00989134-20100527-96. Epub 2010 Jul 8. — View Citation

Palacios S. Managing urogenital atrophy. Maturitas. 2009 Aug 20;63(4):315-8. doi: 10.1016/j.maturitas.2009.04.009. Epub 2009 Jun 2. Review. — View Citation

Vaginal atrophy. Managing vaginal dryness and irritation. Mayo Clin Health Lett. 2012 Oct;30(10):6. — View Citation

Woods NF. An overview of chronic vaginal atrophy and options for symptom management. Nurs Womens Health. 2012 Dec;16(6):482-93; quiz 494. doi: 10.1111/j.1751-486X.2012.01776.x. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Successful vaginal placement and removal	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.	14 days	No
Primary	Vaginal lubrication/moisturization	Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted.	14 days	No
Secondary	Comfort and fit of intravaginal ring	Assessment of patient satisfaction with the comfort and fit of the intravaginal ring during the study period.	14 days	No