Vulvo Vaginal AtrophyNCT07367061
Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)
A study testing product: Innea Aqua vaginal use in people with Vulvo Vaginal Atrophy, run by Innate srl at 3 sites in Romania.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Vulvo Vaginal Atrophy
- What is being tested?
- product: Innea Aqua vaginal use
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesRomania
- Study dates
- 25 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 15Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Romania3 sites
Obstretics and Gynaecology Filantropia Clinical Hospital
Bucharest, Romania, 011132
Nicolae Malaxa Clinical Hospital
Bucharest, Romania, 022441
AMCA Medical Clinic
Bucharest, Romania, 030863
About this study
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
- Vulvo Vaginal Atrophy
- Being tested
- product: Innea Aqua vaginal use, arm 2: standard of care
- Keywords
- VVA, hyaluronic acid, vulvo vaginal atrophy, vaginal atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
product: Innea Aqua vaginal useDevice
product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.
arm 2: standard of careDevice
the comparator is the standard of care selected by the centre
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: randomized to the treatment Innea Aqua | Experimental | 31 women (18-75) treated with product Innea Aqua. 1 injection of the product and after 30 days another injection Receives: Device: product: Innea Aqua vaginal use |
| Arm 2: randomized to the treatment to the standard of care | Active comparator | standard of care tratment Receives: Device: arm 2: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Secondary outcomes (12)
Efficacy: change in pruritus
Change in Pruritus (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start25 Sep 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvo Vaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open, double-arm, prospective, multicenter clinical investigation to evaluate the safety and efficacy of INNEA AQUA in adult women aged 18-75 with Vulvo-vaginal atrophy (VVA). The enrollment period will be 6 months, and the clinical investigation period will be up to 12 weeks per patient.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innate srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEBIS International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367061
- Sponsor's protocol ID
- INN-AQA-10/24
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)
- ClinicalTrials.gov ID
- NCT07367061
- Acronym / sponsor ID
- INN-AQA-10/24
- Conditions
- Vulvo Vaginal Atrophy
- Keywords
- VVA, hyaluronic acid, vulvo vaginal atrophy, vaginal atrophy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Innate srlIndustry (pharma, biotech, devices)
- Collaborators
- CEBIS International
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open, double-arm, prospective, multicenter clinical investigation to evaluate the safety and efficacy of INNEA AQUA in adult women aged 18-75 with Vulvo-vaginal atrophy (VVA). The enrollment period will be 6 months, and the clinical investigation period will be up to 12 weeks per patient.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: randomized to the treatment Innea Aqua | Experimental | Device: product: Innea Aqua vaginal use31 women (18-75) treated with product Innea Aqua. 1 injection of the product and after 30 days another injection |
| Arm 2: randomized to the treatment to the standard of care | Active comparator | Device: arm 2: standard of carestandard of care tratment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| product: Innea Aqua vaginal useproduct object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua. | Device | Arm 1: randomized to the treatment Innea Aqua |
| arm 2: standard of carethe comparator is the standard of care selected by the centre | Device | Arm 2: randomized to the treatment to the standard of care |
Primary outcome
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
12 secondary outcomes
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
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
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
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
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
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
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
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
safety (AE/SAE)
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
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
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
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Vulvo Vaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Active, not recruiting
Evaluation of the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in Postmenopausal Breast Cancer Survivors
Vulvo Vaginal Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing product: Innea Aqua vaginal use in people with Vulvo Vaginal Atrophy, run by Innate srl at 3 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.