NCT06922136

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

A Prospective, Randomized, Controlled, 2-arms, Double-blind, Multicentre Clinical Investigation to Evaluate the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in the Management of Vulvovaginal Atrophy in Postmenopausal Breast Cancer Survivors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: Female
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This will be a prospective, randomized, controlled, 2-arms, placebo-controlled, double-blind, multicentre clinical investigation. Patients with good compliance and who are voluntary to sign the informed consent will be enrolled in a period time of approximately 6 months. The screened and eligible patients will be randomly assigned in one of the two groups: Group A will receive Hyalo Gyn® and Group B will receive Placebo. Neither the Investigator nor the Patient will be aware of the assigned treatment. Subjects of both groups will start the treatment with 1 application of Hyalo Gyn® gel or placebo gel, 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), according to the status of dryness symptom, measured with the VRS dryness score from baseline to 12 weeks, patients will undergo different procedures for the second phase of the study as reported in the brief summary. Visits at the investigational site will be performed at screening/baseline (V0, Week 0) and every 4 weeks, alternated to telephone contacts by the clinician (V1, Week 4; T1, Week 6; V2, Week 8; T2, Week 10; V3, Week 12) up to the end of the first 12-week phase of the study. Two phone follow-up visits will be performed at Week 16 (T3) and Week 20 (T4), followed by a visit at the investigational site at the end of the second 12-week phase of the study (V4, Week 24). Visit 4 (Week 24) will represent the end of study visit. In case of premature withdrawal from the investigation for whatever reason an "Early termination Visit" will be performed, which will include all assessments foreseen for the final visit (Visit 4, Week 24 ± 5 days).

Conditions

• Vulvo Vaginal Atrophy

Interventions

Type	Name	Description
DEVICE	Hyalo Gyn Vaginal Gel	Hyalo Gyn® is uniquely formulated with Hydeal-D®, a proprietary HA derivative component manufactured by Fidia Farmaceutici S.p.A.
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-01-30
• Completion: 2026-05-01
• First posted: 2025-04-10
• Last updated: 2026-02-12

Locations

7 sites across 1 country: Italy