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

What this trial studies

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).

Conditions in scope

• Genitourinary Syndrome of Menopause

Interventions

• High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid (Device) — five treatment sessions of high-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid 2 weeks apart with a duration of approximately 15 minutes
• hyaluronic acid-based gel (Hydeal-D®) (Device) — hyaluronic acid-based gel (Hydeal-D®) applied once every three days for 12 weeks

Who can join

Women only · Ages 18 Years and up

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).

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2023-10-16
• Primary completion: 2025-12
• Last update posted: 2025-03-17
• First posted: 2025-03-17

Sponsor & contact

Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• vaginal dryness one month after the completion of treatment (one month)
  comparison of the two treatment arms for the percentage of patients with a moderate or severe degree of vaginal dryness according to the Most Bothersome Symptoms - MBS scale (scores 2-3) one month after the end of treatment in the total enrolled women (Cohort 1 + Cohort 2).

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.