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

NCT06879938 | Recruiting

• 1 other identifier: Caress
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• vaginal dryness one month after the completion of treatment

  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).

  one month

Secondary Outcomes (1)

• treatment compliance

  one month

Study Arms (2)

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

EXPERIMENTAL

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

Hyaluronic acid-based gel (Hydeal-D®) applied once every three days

ACTIVE COMPARATOR

Device: hyaluronic acid-based gel (Hydeal-D®)

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

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

hyaluronic acid-based gel (Hydeal-D®) DEVICE

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

Hyaluronic acid-based gel (Hydeal-D®) applied once every three days

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

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

Pavia, Pavia, 27100, Italy

RECRUITING

Central Study Contacts

Rossella Nappi, MD

CONTACT

+390382503325; r.nappi@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: October 16, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-02

Locations

IT (1)