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

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2025-12-31

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

Conditions

Genitourinary Syndrome of Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid

Group Type: EXPERIMENTAL

High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid

Intervention Type: 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®) applied once every three days

Group Type: ACTIVE_COMPARATOR

hyaluronic acid-based gel (Hydeal-D®)

Intervention Type: DEVICE

hyaluronic acid-based gel (Hydeal-D®) applied once every three days for 12 weeks

Interventions

High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid

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

Intervention Type: DEVICE

hyaluronic acid-based gel (Hydeal-D®)

hyaluronic acid-based gel (Hydeal-D®) applied once every three days for 12 weeks

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Rossella Nappi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita

Pavia, Pavia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Rossella Nappi, MD

Role: CONTACT

r.nappi@smatteo.pv.it

+390382503325

Facility Contacts

Rossella Nappi, MD

Role: primary

r.nappi@smatteo.pv.it

+390382503325

Other Identifiers

Caress

Identifier Type: -

Identifier Source: org_study_id