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New vaginal device aims to ease Menopause-Linked discomfort

NCT ID NCT07367061

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

62 people

The number who actually took part.

Started

Sep 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

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

  • AMCA Medical Clinic

    Bucharest, Romania, 030863, Romania

  • Nicolae Malaxa Clinical Hospital

    Bucharest, Romania, 022441, Romania

  • Obstretics and Gynaecology Filantropia Clinical Hospital

    Bucharest, Romania, 011132, Romania

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