Phase
Condition
Vaginal Atrophy
Treatment
hyaluronic acid-based gel (Hydeal-D®)
High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid
Clinical Study ID
Ages > 18 Female
Study Summary
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
Connect with a study center
Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita
Pavia, 27100
ItalyActive - Recruiting
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