Vaginal device aims to boost infection treatment

NCT ID NCT07703241

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests whether a vaginal ovule device, used alongside standard antibiotics or antifungals, improves vaginal health in women with bacterial vaginosis or yeast infections. Eighty women aged 18 to 60 receive either the active device or a placebo ovule over three treatment cycles. The main goal is to see if the device improves a composite Vaginal Health Index score, with secondary measures including pH, symptoms, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a Class IIa vaginal medical device (INTIMIQUE OVULI) containing lactic acid, tyndallized probiotics, and sodium hyaluronate
What this could lead to
If effective, this device could provide a safe, non-drug option to help treat and prevent recurring vaginal infections when used with standard medication.
What could go wrong
This is a small, early-stage study with only 80 participants, so results may not apply to everyone. The device is an add-on, not a standalone cure, and its benefits over placebo are uncertain.

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Nov 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 60 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: * Female sex * Age 18 to 60 years * Able to understand and sign informed consent * Able to understand and comply with protocol requirements * Negative pregnancy test * Negative HIV test * Not taking, and agreeing not to take, any other medication or medical device for the duration of the study, except the elective antibacterial or antifungal treatment for BV or VVC * Presenting symptoms suggestive of BV or VVC at screening (leukorrhea, itching, burning) * Confirmed clinical diagnosis of bacterial vaginosis (yellow-green or gray vaginal discharge; vaginal pH \> 4.5; positive whiff test/fishy odor with potassium hydroxide), OR * Confirmed clinical diagnosis of vulvovaginal candidiasis (gynecological examination with itching, burning, thick white discharge; vaginal pH typically \< 4.5; vaginal swab confirmation of \*Candida\* spp.) Exclusion Criteria: * Male sex * Age \< 18 or \> 60 years * Pregnant, suspected pregnant, or planning pregnancy during the study period * Breastfeeding * Not self-sufficient * Unwilling/unable to cooperate with study procedures * Unable to attend the study site within the required timeframe * Judged unsuitable by the investigator due to other conditions incompatible with enrollment requiring pharmacological treatment * HIV-positive / acquired immunodeficiency * Known allergy to components of the investigational products (active or placebo) * Presence of vaginal infections other than BV or VVC * Alcohol, drug, nicotine, or excessive caffeine/theine abuse * Use of vaginal or systemic antifungal/antibiotic treatment within the 7 days prior to enrollment * Taking any other medication or medical device during the study period, except the elective treatment for BV/VVC\* * Systemic or immunosuppressive conditions interfering with symptom interpretation * Participation in another clinical study within the previous 30 days * If pharmacological treatment becomes necessary, this must be reported to the Principal Investigator, who will assess on a case-by-case basis whether the subject should be excluded.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinica Mediterranea

    Naples, 80122, Italy

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