Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vagi… (NCT07367061) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)
Romania62 participantsStarted 2025-09-25
Plain-language summary
Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA).
To assess the Safety and efficacy of INNEA AQUA
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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:
* 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,…
What they're measuring
1
safety: Incidence of AE and SAE
Timeframe: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection