Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomize

Recruiting N/A Interventional Study
Genitourinary Syndrome of Menopause
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia · Other
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About This Trial
The Caress study is a single-center, open-label, randomized controlled trial (RCT) evaluating the efficacy of a combined treatment using topical hyaluronic acid and high-concentration oxygen therapy (Vaginal Natural Oxygenation Device - VNOD) in improving symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women, including those with a history of breast cancer. The primary obje…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Informed consent signature * Willingness to undergo treatment and follow-up evaluations according to the schedule outlined in the protocol * Age \> 18 years Cohort 1: * Diagnosis of non-metastatic breast cancer (M0/Mx according to TNM system) who have undergone surgical and/…
Contacts

Rossella Nappi, MD

+390382503325

r.nappi@smatteo.pv.it

CONTACT