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, Randomized Study
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-03-17
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new combined treatment of topical hyaluronic acid and high-concentration oxygen therapy using the Vaginal Natural Oxygenation Device (VNOD) to improve symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women, including those with a history of breast cancer. This open-label, randomized controlled trial aims to assess vaginal dryness and other related symptoms such as pain, irritation, itching, sexual health, and quality of life. The study will include 80 women divided equally between those with and without breast cancer history, with results analyzed statistically to compare symptom improvement between treatments. The study compares two treatments: one group receives five sessions of high-concentration vaginal oxygen therapy combined with topical hyaluronic acid spaced two weeks apart, each lasting about 15 minutes. The other group uses a hyaluronic acid-based gel (Hydeal-D®) applied once every three days for 12 weeks. This design allows evaluation of the combined device and gel therapy versus gel alone over the treatment period. Participants will undergo treatment and follow-up evaluations according to the study schedule, with primary measurement focused on vaginal dryness one month after treatment completion. Secondary assessments include monitoring treatment compliance and evaluating additional vaginal symptoms up to six months after treatment. The study duration is 18 months, aiming to offer a non-hormonal option to improve quality of life for postmenopausal women, particularly those with breast cancer history. Safety monitoring and symptom tracking are part of the study process.
CONDITIONS
Brief 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 scheduled
- Age over 18 years
- For breast cancer cohort: diagnosed non-metastatic breast cancer with prior treatments completed
- Postmenopausal status confirmed by hormone levels or specific treatments for at least 6 months
- Moderate vaginal dryness (score 2 or 3 on MBS scale)
- Pelvic static alterations not exceeding POP-Q score 2
You will not qualify if you...
- Current therapies for vulvo-vaginal atrophy symptoms except lubricants during sexual activity
- Hormone replacement therapy ongoing or stopped less than 6 months ago
- Active vulvo-vaginal or urinary infections
- Abnormal bleeding
- Pathological pap-test within the last 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive five treatment sessions of high-concentration vaginal oxygen therapy with topical hyaluronic acid spaced 2 weeks apart, and apply hyaluronic acid-based gel once every three days for 12 weeks.
5 visits for oxygen therapy sessions and multiple gel applications every three days
Duration - 1 month
Participants are assessed for vaginal dryness and treatment compliance one month after completing treatment.
1 visit (in-person)
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
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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