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New vaginal device shows promise for yeast infections in small trial

NCT ID NCT05507333

Disease control Sponsor: Gedea Biotech AB Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a vaginal pessary (Gedea) in 26 women with yeast infections. Participants used the device daily for 6 days. Researchers checked if symptoms like itching and burning went away by day 7 to 14. The goal was to see if the device could safely treat the infection without medication.

What this could mean

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

Active substance
Gedea pessary (a vaginal insert device)
What this could lead to
If it works, this could offer a new non-drug option for treating yeast infections, potentially reducing symptoms and clearing the infection.
What could go wrong
This is a small, early-phase study with only 26 participants, so results may not apply to everyone. The device may not work as well as standard antifungal treatments.

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

26 people

The number who actually took part.

Started

Mar 2023

Finished

Mar 2024

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 years and older

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: 1. Having decisional capacity and providing written informed consent. 2. Adult, post-menarchal, pre-menopausal women, aged 18 years or older 3. Diagnosis of VVC, defined as: * Having a white or creamy vaginal discharge * At least 2 of the following signs and symptoms of VVC that are characterised as at least moderate: itching, burning, irritation, oedema, erythema, or excoriation. * KOH or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts. 4. Negative urine pregnancy test at Screening. 5. Refrain from using any intravaginal products (i.e. contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) until Day 14. 6. Refrain from sexual intercourse or use a condom until Day 7. 7. Signed informed consent and willing and able to comply with all study requirements. Exclusion Criteria: 1. Patients with known or apparent signs of other infectious causes of vaginal infection (BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at Screening. 2. Patients who are pregnant or breastfeeding. 3. Patients who were treated for VVC within 14 days prior to Screening. 4. Patients who are currently receiving anti-fungal therapy unrelated to VVC or has taken anti-fungal therapy within 14 days prior to Screening. 5. Patients who have received an investigational drug in a clinical investigation within 30 days prior to Screening. 6. Known/previous allergy or hypersensitivity to any product constituent or fluconazole. 7. Any medical condition that in the Investigator's judgements would make the patient unsuitable for inclusion. 8. More than 3 previous VVC infections during the last 12 months.

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Conditions

The condition(s) this trial relates to.

female reproductive system disorder vaginal disorder vaginitis vulvovaginal candidiasis vulvovaginitis

As listed by the trial registrant

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

Vulvovaginal candidiasis

Contacts and locations

Locations

  • CTC MTC

    Uppsala, 75237, Sweden

  • Carlanderska

    Gothenburg, 405 45, Sweden

  • Danderyds sjukhus

    Stockholm, 182 88, Sweden

  • KS Huddinge

    Stockholm, 141 86, Sweden

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