Actively Recruiting
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
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-03-17
80
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 objective is to assess vaginal dryness improvement one month after treatment, comparing two groups: an experimental group receiving VNOD therapy with hyaluronic acid and a control group using a hyaluronic acid-based gel (Hydeal-D®). Secondary endpoints include the evaluation of additional vaginal symptoms (pain, irritation, itching, sexual health, quality of life) up to six months post-treatment. The study will enroll 80 women (40 with a history of breast cancer and 40 without). Statistical analysis will use chi-square tests and logistic regression to compare symptom severity reduction between the two groups. With a duration of 18 months, the study aims to provide an innovative, non-hormonal treatment option to improve the quality of life for postmenopausal women, particularly those with a history of breast cancer
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Willingness to undergo treatment and follow-up as per study schedule
- Age over 18 years
- For women with history of non-metastatic breast cancer: postmenopausal status by natural or surgical cause or iatrogenic, or premenopausal women on certain hormonal treatments for at least 6 months
- Moderate vaginal dryness (score 2-3 on MBS scale) with vulvovaginal atrophy
- Pelvic static alterations not exceeding POP-Q score 2
- For women without breast cancer: postmenopausal for at least 6 months or bilateral adnexectomy at least 6 months prior
- Moderate vaginal dryness (score 2-3 on MBS scale) with vulvovaginal atrophy
- Pelvic static alterations not exceeding POP-Q score 2
You will not qualify if you...
- Current therapies targeting vulvovaginal atrophy symptoms, except lubricants if sexually active
- Hormone replacement therapy ongoing or stopped less than 6 months ago
- Active vulvovaginal or urinary infections
- Unexplained vaginal bleeding
- Abnormal pap test within last 12 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
R
Rossella Nappi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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