Comparison of Hyalo Gyn® Gel and placebo for vaginal dryness in 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

This study tests whether Hyalo Gyn® gel can help breast cancer survivors with vaginal dryness feel better compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 25 Years to 80 Years
• Sex: Female
• Sponsor: Fidia Farmaceutici s.p.a. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 6 sites (Bologna, BO and 5 other locations)
• Trial ID: NCT06922136 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Hyalo Gyn® gel in treating vulvovaginal atrophy in postmenopausal breast cancer survivors. Participants will be randomly assigned to receive either the gel or a placebo, with applications every three days for 12 weeks. After this initial phase, treatment will be adjusted based on the severity of symptoms. The study aims to provide a controlled environment to assess the gel's impact on vaginal dryness and overall quality of life.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 25 to 80 with a history of breast cancer and moderate to severe vulvovaginal dryness.

Not a fit: Patients who are not postmenopausal or those without a history of breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for postmenopausal breast cancer survivors experiencing vaginal dryness.

How similar studies have performed: Previous studies have shown promise in using similar approaches for treating vulvovaginal atrophy, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent prior to beginning specific protocol procedures;
2. Women between 25 and 80 years of age (inclusive);
3. Women with intention or willingness to have sex;
4. 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;
5. 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);
6. Life expectancy of at least 12 months;
7. 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;
8. 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;
9. Vaginal Health Index ≤15;
10. Vaginal pH ≥5;
11. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1;
12. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
13. 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.

Exclusion Criteria:

1. Stage IIIB-IV breast cancer;
2. Treatment with any other current anti-tumoral therapy besides an AI or tamoxifen or a GnRH analogue;
3. 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;
4. Postmenopausal uterine bleeding and/or vaginal bleeding of unknown aetiology;
5. 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;
6. Patients who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study;
7. Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV), confirmed with a vaginal swab;
8. Patients with a history of vulvovaginal contact allergy or with a diagnosis of vulvovaginal lichen;
9. Positive history of hypersensitivity to hyaluronic acid (HA) or to any component of the medical device;
10. 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);
11. Known human immunodeficiency virus infection;
12. 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;
13. Previous investigational treatment for any condition or participation in any clinical trial in the previous month before inclusion date

Where this trial is running

Bologna, BO and 5 other locations

• Policlinico SantOrsola Malpighi — Bologna, Bo, Italy (Recruiting)
• AOUC Azienda Ospedaliero-Universitaria Careggi — Firenze, Fi, Italy (Recruiting)
• Istituto Europeo di Oncologia — Milano, Mi, Italy (Recruiting)
• Fondazione IRCCS Policlinico San Matteo — Pavia, Pv, Italy (Recruiting)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Rm, Italy (Recruiting)
• AO Ordine Mauriziano di Torino, Ospedale Umberto I — Torino, To, Italy (Recruiting)

Study contacts

• Study coordinator: Nicola Giordan

Conditions Vulvo Vaginal Atrophy