New yeast infection pill could stop repeat episodes

NCT ID NCT03561701

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new oral medication, oteseconazole, to see if it can prevent recurrent yeast infections in women who have had at least three infections in the past year. Over 400 participants took either the study drug or a placebo for 12 weeks after an initial treatment, and were followed for 48 weeks. The goal was to see if the drug could reduce the number of repeat infections.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

425 people

The number who actually took part.

Started

Aug 2018

Finished

Aug 2021

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

12 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.

Key Inclusion Criteria: * 3 or more episodes of acute VVC in the past 12 months * Positive KOH or Gram stain test * Total vulvovaginal signs and symptoms score of ≥3 at screening visit * Total vulvovaginal signs and symptoms score of \<3 at baseline visit * Must be able to swallow pills Key Exclusion Criteria: * Presence or a history of another vaginal or vulvar condition(s) * Evidence of major organ system disease * History of cervical cancer * Poorly controlled diabetes mellitus * Pregnant * Recent use of topical or systemic antifungal or antibacterial drugs * Recent use of immunosuppressive or systemic corticosteroid therapies

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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

  • 31204

    Homestead, Florida, 33030, United States

  • 31215

    Phoenix, Arizona, 85032, United States

  • 31217

    Los Angeles, California, 90057, United States

  • 31218

    Jackson, Tennessee, 38305, United States

  • 31222

    Englewood, Ohio, 45322, United States

  • 31223

    Winston-Salem, North Carolina, 27103, United States

  • 31227

    Little Rock, Arkansas, 72212, United States

  • 31229

    Columbus, Ohio, 43231, United States

  • 31232

    Frisco, Texas, 75035, United States

  • 31233

    North Bay Village, Florida, 33141, United States

  • 31240

    Hartford, Connecticut, 06105, United States

  • 31244

    Columbus, Ohio, 43213, United States

  • 31245

    Hagerstown, Maryland, 21740, United States

  • 31255

    Wichita, Kansas, 67226, United States

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