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Condition / disease
Location
Status: Not yet recruiting

Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopause (GSM)

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.

Participants needed: 60
Trial details
Biological sex: FemaleType: InterventionalSponsor: AVeta MedicalUpdated: Jan 10, 2025Locations: 2
Eligibility criteria

Healthy postmenopausal subjects from 1 to 15 years since their last menstrual cy... [+16]

Subjects on Hormone Therapies (HT), systemic or local, or within 6 months of ces... [+19]