Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT04355403
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels \>40 IU/L), both natural postmenopause or medical postmenopause (breast cancer patients undergoing a concurrent treatment with aromatase inhibitors or tamoxifen).
* Women between 18 and 75 years of age.
* Vaginal pH ≥5.
* Vulvovaginal atrophy with VHI \< 15.
* At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity.
* Women with active sex life.
* Patients who give written informed consent to participate in the trial.
Exclusion Criteria:
* Treatment with another investigational product within the previous 3 months.
* Previous participation in any clinical study with Hydeal-D based investigational products.
* Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
* Patients in previous treatment with either oral or topical hormonal products within 1 month.
* Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); history of vulvovaginal contact allergy or with a diagnose of vulvovaginal lichen.
* Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
* Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
* Any condition in the investigator's opinion not suitable for the inclusion of the patient.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04355403
Study Brief:
Protocol Section:
NCT04355403