Evaluation of the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in Postmenopausal … (NCT06922136) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in Postmenopausal Breast Cancer Survivors
Italy156 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range
25 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
. 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;
Exclusion criteria
. 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;