Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness
| Status: | Completed |
|---|---|
| Conditions: | Vaginitis |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | May 2014 |
VR101: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness
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.
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.
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
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
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
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