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
SexFEMALE
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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.
✓. The subject is anatomically suitable to the intravaginal tip as determined by the Investigator.
Exclusion criteria
✕. Subjects on Hormone Therapies (HT), systemic or local, or within 6 months of cessation of HT prior to inclusion in the study.
✕. Subjects with bleeding disorders.
✕. Subjects with any sexually transmitted disease.
✕. Subjects on prescribed anticoagulants such as antiplatelets and anticoagulants (Heparin, Warfarin, Clopidogrel, Apixaban, Rivaroxaban).
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.