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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07367061
Eligibility Criteria:
Inclusion Criteria:
* Adult women aged 18-75 (both fertile and post-menopausal)
* Vulvovaginal atrophy diagnostic
* Signed written informed consent.
* Vaginal Ph more than 4.5
* Willing to sign the informed consent form
* Willing to comply with the clinical investigation visits.
Exclusion Criteria:
* patients who tend to develop hypertrophic scarring,
* patients with a history of autoimmune disease or who are receiving immune therapy,
* patients who are known to be hypersensitive or allergic to hyaluronic acid and other INNEA AQUA components,
* pregnant or breastfeeding women,
* patients under 18 years of age,
* vagina with hypertrophic scars from different etiology,
* patients with presence of ≥ stage 2 apical pelvic organ prolapse,
* patients with stress urinary incontinence,
* patients with vaginismus, vulvovaginal or urinary tract infection,
* patients with Hemorrhagic or neoplastic genital pathologies or hormone-dependent tumor
* patients with genital bleeding of unknown etiology, recurrent porphyria, uncontrolled epilepsy, heart conduction disorders, recurrent angina, rheumatic fever, previous vulvovaginal or uro-gynecological surgery, and hemostatic disorders,
* Anticoagulated patients or patients receiving platelet aggregation inhibitors should not be treated with INNEA AQUA,
* INNEA AQUA must not be used in areas presenting inflammatory and/or infectious processes (e.g., papilloma, herpes). INNEA AQUA must not be used in association with other invasive treatments,
* Avoid using in combination with any other concomitant therapies for same indication;
* Patients who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at treatment sites.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07367061
Study Brief:
Protocol Section:
NCT07367061