Intravaginal Device for Genitourinary Syndrome

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByNancy Philips

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: AVeta Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for post-menopausal women with moderate to severe pain during intercourse due to Genitourinary Syndrome of Menopause (GSM). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.

Inclusion Criteria

I have been sexually active in the last month.

Normal Papanicolaou test within the past year (or should be done 2 weeks before the trial begins). Subject can ONLY participate on negative results

I plan to be sexually active at least twice a month during the trial.

+14 more

Exclusion Criteria

I do not have any active genital infections.

Abnormal Papanicolaou test within the past year

Positive pregnancy test or planned pregnancy during the study period

+17 more

Participant Groups

The VITA AV Clinical System, a medical device designed to alleviate symptoms of GSM, is being tested against a sham (no treatment) device. The study will monitor the safety and effectiveness up to three months after the last treatment and include long-term follow-up visits.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TreatmentExperimental Treatment1 Intervention

The VITA AV Clinical System (consisting of the VITA AV Probe Kit and the Medela Pump), has a white connector component, part number 10531-01, to allow the vacuum to be delivered to the vaginal tissue when then vacuum pump is activated.

Group II: Sham TreatmentPlacebo Group1 Intervention

The VITA AV Clinical System (consisting of the VITA AV Probe Kit and the Medela Pump), has a black connector component, part number 10531-02, to block and prevent the vacuum from being delivered to the vaginal tissue when then vacuum pump is activated.