Clinical trial NCT02029053: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Menopausal and Perimenopausal Disorder, Unspecified
Atrophic Vaginitis
Keywords: Vaginal dryness
Vaginal lubrication
Post-menopausal symptoms
Peri-menopausal symptoms
Urogenital atrophy
Dyspareunia
Painful intercourse
Lead sponsor: J3 Bioscience, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Utah
First posted: 2014-01-07
Enrollment: 21
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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:

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 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

Primary outcomes:
measure: Vaginal lubrication/moisturization
timeFrame: 14 days
Secondary outcomes:
measure: Comfort and fit of intravaginal ring
timeFrame: 14 days
Other outcomes:
measure: Successful vaginal placement and removal
timeFrame: 14 days
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah
name: Margit Janat-Amsbury, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Vaginal atrophy. Managing vaginal dryness and irritation. Mayo Clin Health Lett. 2012 Oct;30(10):6. No abstract available.
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.
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.
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.