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

Primary Purpose

Menopausal and Perimenopausal Disorder, Unspecified, Atrophic Vaginitis

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vaginal Lubrication Ring for Vaginal Dryness

About this trial

This is an interventional supportive care trial for Menopausal and Perimenopausal Disorder, Unspecified focused on measuring Vaginal dryness, Vaginal lubrication, Post-menopausal symptoms, Peri-menopausal symptoms, Urogenital atrophy, Dyspareunia, Painful intercourse

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Utah Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm Study

Arm Description

Vaginal Lubrication Ring for Vaginal Dryness

Outcomes

Primary Outcome Measures

Vaginal lubrication/moisturization

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

Secondary Outcome Measures

Comfort and fit of intravaginal ring

Assessment of patient satisfaction with the comfort and fit of the intravaginal ring during the study period.

Full Information

NCT ID

NCT02029053

First Posted

January 3, 2014

Last Updated

December 14, 2015

Sponsor

J3 Bioscience, Inc.

Collaborators

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT02029053

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

J3 Bioscience, Inc.

Collaborators

University of Utah

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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: Vaginal health index scoring assessed by a member of the research team Participant answers to questionnaires Study objectives will assess the following: Successful placement of VR101 intravaginal ring into the vagina Ease of insertion and removal Comfort and fit Lubrication/ moisturization of the vagina

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menopausal and Perimenopausal Disorder, Unspecified, Atrophic Vaginitis

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm Study

Arm Type

Other

Arm Description

Vaginal Lubrication Ring for Vaginal Dryness

Intervention Type

Device

Intervention Name(s)

Vaginal Lubrication Ring for Vaginal Dryness

Other Intervention Name(s)

VR101, Intravaginal Ring

Intervention Description

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.

Primary Outcome Measure Information:

Title

Vaginal lubrication/moisturization

Description

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Comfort and fit of intravaginal ring

Description

Assessment of patient satisfaction with the comfort and fit of the intravaginal ring during the study period.

Time Frame

14 days

Other Pre-specified Outcome Measures:

Title

Successful vaginal placement and removal

Description

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.

Time Frame

14 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margit Janat-Amsbury, MD, PhD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Utah Health Sciences Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19493638

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.

Results Reference

background

PubMed Identifier

23133861

Citation

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

Results Reference

background

PubMed Identifier

23253575

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.

Results Reference

background

PubMed Identifier

21672177

Citation

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.

Results Reference

background

PubMed Identifier

20608584

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.

Results Reference

background

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

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