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

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Mar 11, 2025

Keywords

ClinConnect Summary

The Caress study is a clinical trial that is looking at a new treatment for women experiencing symptoms of Genitourinary Syndrome of Menopause (GSM), which can include vaginal dryness, pain, and irritation. This trial is specifically for postmenopausal women, including those with a history of breast cancer. The study will compare two groups: one group will receive a combination of topical hyaluronic acid and a special oxygen therapy device, while the other group will use a standard hyaluronic acid gel. The aim is to see if the new treatment improves symptoms better than the standard treatment, particularly looking at changes in vaginal dryness after one month and other symptoms over six months.

To be eligible for the study, women must be at least 18 years old and have moderate vaginal dryness. Participants should either be postmenopausal or have gone through certain cancer treatments that have caused menopause. They cannot be receiving other treatments for vaginal symptoms or have certain infections. If you join the study, you'll undergo treatment and have regular follow-up evaluations. This trial is important because it may offer a non-hormonal option that could improve the quality of life for many women facing these challenging symptoms.

Gender

FEMALE

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.