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Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA) | Clinical Trials | Clareo Health

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Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)

NCT07367061•Innate srl

View on ClinicalTrials.gov

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

Detailed Description

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

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

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
+5 more criteria

Locations (3)

Obstretics and Gynaecology Filantropia Clinical Hospital

Bucharest, Romania, Romania

Nicolae Malaxa Clinical Hospital

Bucharest, Romania, Romania

AMCA Medical Clinic

Bucharest, Romania, Romania

Key Dates

Start Date

September 25, 2025

Primary Completion Date

May 30, 2026

Completion Date

June 30, 2026

Last Updated

February 9, 2026

Enrollment

ACTUAL participants

Conditions

Vulvo Vaginal Atrophy

Interventions

product: Innea Aqua vaginal use

DEVICE

arm 2: standard of care

DEVICE

Regenerative Treatment of Female Genital Atrophy

NCT07306611

Vulvo Vaginal Atrophy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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