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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: r.nappi@smatteo.pv.it
• Phone: +390382503325

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.