Combining topical hyaluronic acid with high-concentration oxygen therapy for menopausal symptoms

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

This study is testing if a treatment that combines a special gel and high-concentration oxygen can help postmenopausal women, including those who had breast cancer, feel better by reducing vaginal dryness and other symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Pavia, Pavia)
• Trial ID: NCT06879938 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a combined treatment using topical hyaluronic acid and high-concentration oxygen therapy (Vaginal Natural Oxygenation Device - VNOD) to alleviate symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women, including those with a history of breast cancer. The study is an open-label, randomized controlled trial conducted at a single center, enrolling 80 women divided into two groups: one receiving the combined treatment and the other using a hyaluronic acid-based gel. The primary outcome is the improvement in vaginal dryness after one month, with secondary outcomes assessing additional vaginal symptoms and quality of life up to six months post-treatment. Statistical analyses will compare symptom severity reduction between the two groups.

Who should consider this trial

Good fit: Ideal candidates include postmenopausal women, both with and without a history of breast cancer, experiencing moderate to severe vaginal dryness.

Not a fit: Patients with severe pelvic static alterations exceeding a POP-Q score of 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for women suffering from GSM symptoms.

How similar studies have performed: While the combination of these therapies is innovative, similar approaches have shown promise in improving symptoms related to menopausal conditions.

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.

Where this trial is running

Pavia, Pavia

• Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita — Pavia, Pavia, Italy (RECRUITING)

Study contacts

• Study coordinator: Rossella Nappi, MD

Conditions: Genitourinary Syndrome of Menopause