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

Last updated: March 11, 2025
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Atrophy

Treatment

hyaluronic acid-based gel (Hydeal-D®)

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

Clinical Study ID

NCT06879938
Caress
  • Ages > 18
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent signature

  • Willingness to undergo treatment and follow-up evaluations according to the scheduleoutlined in the protocol

  • Age > 18 years

Cohort 1:

  • Diagnosis of non-metastatic breast cancer (M0/Mx according to TNM system) who haveundergone surgical and/or chemotherapy and/or immunotherapy and/or radiotherapyand/or endocrine treatment.

  • Postmenopausal women (FSH > 30 UIIU/L, E2 < 20 pg/ml), either naturally orsurgically induced, or iatrogenic post-chemotherapy with absent menstrual cycle forat 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 vulvovaginalatrophy (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 forat least 6 months, or women who have undergone bilateral adnexectomy at least 6months ago.

  • At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginalatrophy (score 2-3 on the MBS scale).

  • Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q).

Exclusion

Exclusion Criteria:

  • Other current therapy aimed at resolving symptoms associated with vulvo-vaginalatrophy, 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.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: hyaluronic acid-based gel (Hydeal-D®)
Phase:
Study Start date:
October 16, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

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

    Pavia, 27100
    Italy

    Active - Recruiting

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