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Vaginal device aims to boost infection treatment

NCT ID NCT07703241

Not yet recruiting Disease control Sponsor: ROELMI HPC Source: ClinicalTrials.gov ↗

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.

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Conditions

The condition(s) this trial relates to.

bacterial vaginosis vulvovaginal candidiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BACTERIAL VAGINOSIS CANDIDAL VAGINITIS

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Clinica Mediterranea

    Naples, 80122, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

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