NCT06879938

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

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, Randomized Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2023-10-16
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-03-17
• Last updated: 2025-03-17

Locations

1 site across 1 country: Italy