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Antifungal in pregnancy: researchers follow babies for a year

NCT ID NCT05908682

Knowledge-focused Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time

Summary

Researchers are collecting information on pregnant women who took the antifungal medicine ibrexafungerp, which treats vaginal yeast infections. The study follows their babies from birth through the first year of life, looking for birth defects, growth problems, and developmental issues. It also records pregnancy outcomes such as live births, miscarriages, and preterm deliveries. The goal is to understand whether the medicine is linked to any risks during pregnancy.

What this could mean

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

Active substance
ibrexafungerp, an antifungal medicine for vaginal yeast infections
What this could lead to
If the data show no pattern of harm, doctors could gain clearer guidance on whether ibrexafungerp is safe to use during pregnancy.
What could go wrong
This observational study cannot prove cause and effect, and many pregnancies end in complications for unrelated reasons. A small sample may miss rare birth defects, and self-reported exposure can be inaccurate.

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.

Participants

About 100 people

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

Started

Nov 2025

Expected to finish

Jul 2029

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.

Who is studied

The study population will include women who were exposed to ibrexafungerp at any time during pregnancy or whose conception is estimated to have occurred within four days after receiving last dose of ibrexafungerp, volunteering to take part in this study.

Ages

0 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Exposure to ibrexafungerp during pregnancy or if conception is estimated to have occurred within 4 days of the last dose of ibrexafungerp 2. Subject and/or parent/legal representative consents to participate and agrees to the conditions and requirements of the study including the interview schedule/completion of questionnaire and release of medical records * Subject can be identified by the sponsor or HCP, in terms of confirmed pregnancy. A self-reported pregnancy will be considered as confirmed pregnancy if the Urine Pregnancy Test (UPT) result is positive. * A woman can self-enroll in the study or her healthcare provider (HCP), with her consent, can enroll her on her behalf. Exclusion Criteria: 1. Females who were not exposed to safety study medications during pregnancy 2. Refusal to participate in the study 3. An inability to provide an accurate medical history or give informed consent

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Conditions

The condition(s) this trial relates to.

candidiasis oral candidiasis vulvovaginal candidiasis vulvovaginitis

As listed by the trial registrant

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

Candida infection Vaginal candidiasis Vulvovaginal candidiasis Vulvovaginitis, candidal

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.

    Open the record ↗

  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

  • AWINSA

    RECRUITING

    New Delhi, Vasant Vihar, 110057, India

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