Status:
RECRUITING
Evaluation of the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in Postmenopausal Breast Cancer Survivors
Lead Sponsor:
Fidia Farmaceutici s.p.a.
Conditions:
Vulvo Vaginal Atrophy
Eligibility:
FEMALE
25-80 years
Phase:
NA
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 with...
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 inform...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Previous investigational treatment for any condition or participation in any clinical trial in the previous month before inclusion date
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06922136
Start Date
August 1 2024
End Date
December 1 2025
Last Update
April 10 2025
Active Locations (6)
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1
Policlinico SantOrsola Malpighi
Bologna, BO, Italy, 40138
2
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, FI, Italy, 50134
3
Istituto Europeo di Oncologia
Milan, MI, Italy, 20141
4
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy, 27100