Active, not recruitingNCT07367061Updated Feb 9, 2026

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

An interventional study of product: Innea Aqua vaginal use and arm 2: standard of care in Vulvo Vaginal Atrophy, sponsored by Innate srl. Active, not recruiting at 3 sites in Romania. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Innate srl · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 62
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: Female

Study 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

Read the 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

Conditions studied

Vulvo Vaginal Atrophy

Keywords

VVA
hyaluronic acid
vulvo vaginal atrophy
vaginal atrophy

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 62 participants (actual)

Study arms

Experimental
Arm 1: randomized to the treatment Innea Aqua
31 women (18-75) treated with product Innea Aqua. 1 injection of the product and after 30 days another injection
Device: product: Innea Aqua vaginal use
Active comparator
Arm 2: randomized to the treatment to the standard of care
standard of care tratment
Device: arm 2: standard of care

Interventions

Deviceproduct: Innea Aqua vaginal use
product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.
Devicearm 2: standard of care
the comparator is the standard of care selected by the centre

What researchers measure

Primary outcomes

safety: Incidence of AE and SAE
To evaluate the safety of INNEA AQUA in adult participants. Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

Secondary outcomes

Efficacy: change in pruritus
Change in Pruritus (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Efficacy: Change in soreness
Change in Soreness (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Efficacy: change in dyspareunia
Change in Dyspareunia (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in irritation
Change in Irritation (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of pH
Vaginal Ph Normalization
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in vaginal moisture
Change in Vaginal moisture - Modified Schirmer test (mm) change on Day 30, Day 51, and Day 120 compared with baseline
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in VHX
Change in Vaginal Health Index (VHI) score on Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of vaginal aging
Change in Day-to-Day Impact of Vaginal Aging Questionnaire on Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
safety (AE/SAE)
Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: satisfaction of the patient
Participant satisfaction in using the Device (PGI-I) Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: satisfaction of the investigator
Investigator satisfaction in using the Device (VAS) Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of quality of life
Change in baseline score in QoL score when compared to Day 30, 51 and 120.
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

Study locations

3 sites

Obstretics and Gynaecology Filantropia Clinical Hospital
Bucharest, Romania 011132, Romania
Nicolae Malaxa Clinical Hospital
Bucharest, Romania 022441, Romania
AMCA Medical Clinic
Bucharest, Romania 030863, Romania

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07367061
Lead sponsor: Innate srl
Collaborators: CEBIS International
Responsible party: Sponsor
First posted: Jan 26, 2026
Start date: Sep 25, 2025
Primary completion: May 30, 2026 (estimated)
Completion: Jun 30, 2026 (estimated)
Last update: Feb 9, 2026

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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