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

NCT02029053 | Completed Early Phase 1 DMC

• 1 other identifier: 67709
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopausal and Perimenopausal Disorder, Unspecified; Atrophic Vaginitis

Keywords

Vaginal dryness; Vaginal lubrication; Post-menopausal symptoms; Peri-menopausal symptoms; Urogenital atrophy; Dyspareunia; Painful intercourse

Outcome Measures

Primary Outcomes (1)

• Vaginal lubrication/moisturization

  Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted.

  14 days

Secondary Outcomes (1)

• Comfort and fit of intravaginal ring

  14 days

Other Outcomes (1)

• Successful vaginal placement and removal

  14 days

Study Arms (1)

Single Arm Study

OTHER

Vaginal Lubrication Ring for Vaginal Dryness

Device: Vaginal Lubrication Ring for Vaginal Dryness

Interventions

Vaginal Lubrication Ring for Vaginal Dryness DEVICE

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.

Also known as: VR101, Intravaginal Ring

Single Arm Study

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• J3 Bioscience, Inc.: lead
• University of Utah: collaborator

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (5)

• 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.

  PMID: 19493638 BACKGROUND

• Vaginal atrophy. Managing vaginal dryness and irritation. Mayo Clin Health Lett. 2012 Oct;30(10):6. No abstract available.

  PMID: 23133861 BACKGROUND

• 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.

  PMID: 23253575 BACKGROUND

• 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. No abstract available.

  PMID: 21672177 BACKGROUND

• 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.

  PMID: 20608584 BACKGROUND

MeSH Terms

Conditions

Atrophic Vaginitis; Dyspareunia

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Margit Janat-Amsbury, MD, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 7, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 15, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)