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

Launched by FIDIA FARMACEUTICI S.P.A. · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a product called Hyalo Gyn® gel works compared to a placebo (a treatment that doesn't contain any active ingredients) for treating vulvovaginal atrophy, which is a condition that often causes dryness and discomfort in the vaginal area. The study is specifically for postmenopausal women who have survived breast cancer and are experiencing moderate to severe dryness. Participants will use the gel or placebo every three days for 12 weeks. After this initial period, there are different paths depending on their symptoms: if their dryness improves significantly, they will stop treatment; if it improves but isn't completely gone, they will continue with the gel; and if it worsens, they can choose to continue with the gel or just have follow-up visits.

To be eligible for this trial, women need to be between 25 and 80 years old, have completed their breast cancer treatment within the last 3 to 60 months, and be willing to engage in sexual activity. Participants should also be in a postmenopausal state, meaning they haven't had periods for a year or more. Additionally, they must have moderate to severe symptoms of dryness that are bothersome. It's important for participants to note that they won't be able to use other treatments for vaginal dryness during the trial, except for certain water-based lubricants during sexual activity. If you're interested in participating or want to know more, please reach out to the research team for more information.

Gender

FEMALE

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