Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopaus… (NCT06768073) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopause (GSM)
United States, Georgia60 participantsStarted 2025-03-03
Plain-language summary
This pilot study aims to evaluate the safety and effectiveness of the VITA AV Clinical System over a period of up to three months after the last treatment, compared to a sham device. The study focuses on improving vaginal signs and symptoms of Genitourinary Syndrome of Menopause (GSM) in post-menopausal women who experience moderate to severe pain during intercourse (dyspareunia). Long-term follow-up visits will assess the ongoing effectiveness and durability of the treatment, while also collecting safety data.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy postmenopausal subjects from 1 to 15 years since their last menstrual cycle.
. Willingness to refrain from using alternative therapies for treatment of symptoms of GSM, unless medically necessary, through the duration of this study.
. Moderate to severe dyspareunia associated with GSM. (i.e., ≥4 on the 11-point patient-reported numeric rated dyspareunia scale).
. Subjects who are sexually active (i.e. have had or have attempted to have sexual activity with vaginal penetration within approximately 1 month of screening visit).
. Subjects who anticipate engaging or attempting to engage in sexual activity (with vaginal penetration) at least twice a month during the trial.
. Vaginal Health Index (VHI) score of less than or equal to 15.
. Vaginal pH \>5.0.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Evaluation of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
Timeframe: Baseline to 3-months post the last treatment.
2
Percentage of Vaginal Superficial Cells to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
Timeframe: Baseline to 3-months post the last treatment.
3
Vaginal Moisture Levels to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
Timeframe: Baseline to 3-months post the last treatment.
4
Vaginal pH Levels to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
Timeframe: Baseline to 3-months post the last treatment.