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.
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