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

NCT06922136 | Active Not Recruiting

• 1 other identifier: QQ53-21-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Vulvo Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Evaluation of the performance of Hyalo Gyn® vaginal gel in the improvement of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy, after 12 weeks of treatment, compared to placebo.

  The primary performance endpoint of the investigation will be the change in the vulvovaginal dryness associated with vulvovaginal atrophy, evaluated as the proportion of subjects having a reduction ≥2 points in the Verbal Rating Scale (VRS) dryness score from baseline to 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. The vulvovaginal symptom associated with vulvovaginal atrophy (dryness) will be reported on a four-point scale (0 = absent, 1 = mild, 2 = moderate, 3= severe).

  after 12 weeks of treatment

Secondary Outcomes (9)

• Change from baseline in patient's perception of dryness, irritation/itching, soreness, dysuria, and dyspareunia vulvovaginal symptoms single scores associated with vulvovaginal atrophy

  After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)

• Change from baseline in patient's perception of vulvovaginal symptoms global score associated with vulvovaginal atrophy;

  After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)

• Change from baseline of sexual function through Female Sexual Function Index (FSFI) questionnaire

  After 4, 8 and 12 weeks of treatment from baseline (V0)

• Change from baseline of sexual function through Female Sexual Distress Scale-Revised (FSDS-R) questionnaire

  After 4, 8 and 12 weeks of treatment from baseline (V0)

• Change from baseline of Vaginal Health Index (VHI);

  After 4, 8 and 12 weeks of treatment from baseline (V0),

Study Arms (2)

Group A: Hyalo Gyn® Gel

EXPERIMENTAL

Hyalo Gyn® vaginal gel is formulated with Hydeal-D®, a proprietary HA derivative component

Device: Hyalo Gyn Vaginal Gel

Group B: Placebo

PLACEBO COMPARATOR

Matched plecebo A

Other: Placebo

Interventions

Hyalo Gyn Vaginal Gel DEVICE

Hyalo Gyn® is uniquely formulated with Hydeal-D®, a proprietary HA derivative component manufactured by Fidia Farmaceutici S.p.A.

Group A: Hyalo Gyn® Gel

Placebo OTHER

Placebo

Group B: Placebo

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent prior to beginning specific protocol procedures;
• Women between 25 and 80 years of age (inclusive);
• Women with intention or willingness to have sex;
• Patients with a history of breast cancer who had completed primary cancer treatment (surgery, non-endocrine chemotherapy, or radiation therapy) 3-60 months prior to enrolment;
• Patient receiving endocrine therapy (an AI or tamoxifen or a GnRH analogue) as a breast cancer treatment in the adjuvant setting for a minimum of 3 months. The therapy program must cover the entire duration of the study (24 weeks);
• Life expectancy of at least 12 months;
• Postmenopausal status defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mIU/ml or 6 weeks' postsurgical bilateral oophorectomy with or without hysterectomy;
• Vulvovaginal dryness assessed as moderate to severe. A moderate and severe symptom (i.e. a score of 2 = moderate or 3 = severe) will be considered if the symptoms are present and could be bothersome and could interfere with the normal patient activity;
• Vaginal Health Index ≤15;
• Vaginal pH ≥5;
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1;
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
• Patients legally able to give written informed consent to the trial (signed and dated by the participant) and able to understand study procedures and protocol requirements.

You may not qualify if:

• Stage IIIB-IV breast cancer;
• Treatment with any other current anti-tumoral therapy besides an AI or tamoxifen or a GnRH analogue;
• Prior history of other malignancy other to breast cancer within 5 years of study entry, with the exception of non-melanoma skin cancer or carcinoma in-situ of the uterine cervix adequately treated;
• Postmenopausal uterine bleeding and/or vaginal bleeding of unknown aetiology;
• Patients with endometrial thickness equal to or greater than 4 mm for patientson AI or GnRH analogue, or equal to or greater than 9 mm for patients on tamoxifen, measured by transvaginal ultrasound;
• Patients who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study;
• Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV), confirmed with a vaginal swab;
• Patients with a history of vulvovaginal contact allergy or with a diagnosis of vulvovaginal lichen;
• Positive history of hypersensitivity to hyaluronic acid (HA) or to any component of the medical device;
• Use of any hormone, or any products with phytoestrogenic activity (for instance resveratrol, flax seeds, hops, isoflavones as red clover and soy) for the treatment of menopausal symptoms in the previous month (cimicifuga extract and pollen are allowed);
• Known human immunodeficiency virus infection;
• Other severe acute or chronic medical condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with investigation participation or product administration and investigation's procedures, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this investigation;

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (7)

Policlinico SantOrsola Malpighi

Bologna, BO, 40138, Italy

Location

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, FI, 50134, Italy

Location

Azienda Ospedaliera-Universitaria UOC Clinica Ginecologica e Ostetrica dell'Università

Padua, PD, 35128, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

Location

AO Ordine Mauriziano di Torino, Ospedale Umberto I

Torino, TO, 10128, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The double-blind design for this investigation was made possible by means of the realisation of a placebo that is indistinguishable from the active Hyalo Gyn® gel in terms of shape, colour, consistency, small and mode of application, in order that neither the Investigator nor the study staff, nor the patient will be aware of the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, 2-arms, placebo-controlled, double-blind, multicentre clinical investigation

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 10, 2025
• Study Start: August 1, 2024
• Primary Completion: January 30, 2026
• Study Completion: May 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)