NCT06879938 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
| NCT ID | NCT06879938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Genitourinary Syndrome of Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-10-16 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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/or chemotherapy and/or immunotherapy and/or radiotherapy and/or endocrine treatment. * Postmenopausal women (FSH \> 30 UIIU/L, E2 \< 20 pg/ml), either naturally or surgically induced, or iatrogenic post-chemotherapy with absent menstrual cycle for at least 6 months; or premenopausal women on treatment with LHRH analog +/- tamoxifen and/or aromatase inhibitor for at least 6 months. * At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale). * Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q). Cohort 2: * Postmenopausal women (FSH \> 30 UI/L, E2 \< 20 pg/ml), with absent menstrual cycle for at least 6 months, or women who have undergone bilateral adnexectomy at least 6 months ago. * At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale). * Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q). Exclusion Criteria: * Other current therapy aimed at resolving symptoms associated with vulvo-vaginal atrophy, with the exception of the use of lubricants if sexual activity is present; * HRT in progress or discontinued for less than 6 months; * Ongoing vulvo-vaginal and urinary infections; * Bleeding of ndd; * Pathological pap-test within the previous 12 months.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06879938 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Genitourinary Syndrome of Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06879938 currently recruiting?
Yes, NCT06879938 is actively recruiting participants. Contact the research team at r.nappi@smatteo.pv.it for enrollment information.
Where is the NCT06879938 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06879938 clinical trial?
NCT06879938 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 80 participants.