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

February 5, 2026 updated by: Innate srl

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.
Active Comparator: Arm 2: randomized to the treatment to the standard of care
standard of care tratment
Device: arm 2: standard of care
the comparator is the standard of care selected by the centre

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
safety: Incidence of AE and SAE
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
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
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy: change in pruritus
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Change in Pruritus (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Efficacy: Change in soreness
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Change in Soreness (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Efficacy: change in dyspareunia
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Change in Dyspareunia (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in irritation
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Change in Irritation (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of pH
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Vaginal Ph Normalization
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in vaginal moisture
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Change in Vaginal moisture - Modified Schirmer test (mm) change on Day 30, Day 51, and Day 120 compared with baseline
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in VHX
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Change in Vaginal Health Index (VHI) score on Day 30, Day 51, and Day 120
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of vaginal aging
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Change in Day-to-Day Impact of Vaginal Aging Questionnaire on Day 30, Day 51, and Day 120
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
safety (AE/SAE)
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: satisfaction of the patient
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Participant satisfaction in using the Device (PGI-I) Day 120
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: satisfaction of the investigator
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Investigator satisfaction in using the Device (VAS) Day 120
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
Time Frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Change in baseline score in QoL score when compared to Day 30, 51 and 120.
From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innate srl

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CEBIS International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INN-AQA-10/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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