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
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
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
Innate srl is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
standard of care tratment
Device: arm 2: standard of care
product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.
the comparator is the standard of care selected by the centre
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for May 2026, 8 months after the start.
How these figures are worked out, and which studies are left out of them.
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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