New vaginal device aims to ease Menopause-Linked discomfort
NCT ID NCT07367061
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device called INNEA AQUA, used in the vagina, to see if it safely reduces symptoms of vulvo-vaginal atrophy (VVA) in adult women. VVA can cause itching, soreness, and pain during sex. The trial compares the device to standard care in 62 women aged 18-75. Researchers are tracking side effects and symptom changes over 120 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Innea Aqua (a vaginal device)
- What this could lead to
- If it works, this could offer a new option to ease symptoms like itching, soreness, and pain during sex for women with vulvo-vaginal atrophy.
- What could go wrong
- This is a small, early-stage trial with only 62 participants, so results may not apply to everyone. The device may not work better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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62 people
The number who actually took part.
- Started
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Sep 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AMCA Medical Clinic
Bucharest, Romania, 030863, Romania
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Nicolae Malaxa Clinical Hospital
Bucharest, Romania, 022441, Romania
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Obstretics and Gynaecology Filantropia Clinical Hospital
Bucharest, Romania, 011132, Romania
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