BridgeMD
New treatment option for Genitourinary Syndrome of Menopause
Official title 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
ClinicalTrials.gov ID: NCT06879938
What this study is testing
- What it's testing
- 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®).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- Postmenopausal women (FSH \> 30 UIIU/L, E2 \< 20 pg/ml), either naturally or surgically induced, or iatrogenic post-chemotherapy with absent...
You likely can't join if
- Other current therapy aimed at resolving symptoms associated with vulvo-vaginal atrophy, with the exception of the use of lubricants if sexual...
- 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.
See the full eligibility 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...
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, Pavia, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, Pavia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.