Evaluation of the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in Postmenopausal Breast Cancer Survivors

Eligible patients will be randomized to treatment with Hyalo Gyn® gel or placebo, at the dose regimen of 1 application deeply in the vagina every 3 days (i.e. an application is followed by 2 days without application), up to a total of 12 consecutive weeks. After 12 weeks (i.e. at Visit 3), the following rules will apply for the second 12- week phase of the study: * In case of resolution of the symptom (the dryness single score is equal to zero), the patient will suspend treatment and will undergo follow-up visits; * In case of the single score is reduced but still greater than zero: the subject will receive Hyalo Gyn® open-label. * In case the dryness gets worse the subject can choose whether receive Hyalo Gyn® gel open-label or undergo the follow-up visits. Patients will be allowed to use only water-based lubricants, not containing HA, hormones, or isoflavones, if necessary, only when engaging in sexual activity and specifying the reason for its use (multiple choice answer). The number of lubricant applications, as well as the frequency of the sexual activity, will be recorded weekly in the diary by the patient.

NCT Number	NCT06922136
Lead Sponsor	Fidia Farmaceutici s.p.a.
Conditions	Vulvo Vaginal Atrophy
Enrollment	156 participants
Start Date	2024-08-01
Primary Completion	2026-01-30 (estimated)
Study Completion	2026-05 (estimated)
Updated on ClinicalTrials.gov	2026-02-12