An observational study in Vulvovaginitis, Candidal, Vulvovaginal Candidiasis and Candida Infection, sponsored by GlaxoSmithKline. Recruiting at 1 site in India. Open to female participants aged 0 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by GlaxoSmithKline · Observational
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
This is a single-arm safety study which comprises an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age who were exposed to ibrexafungerp during pregnancy, or whose conception is estimated to have occurred within four days after receiving last dose of ibrexafungerp, and are volunteering to take part in this study. Subjects will be monitored starting from exposure during pregnancy until one year after live delivery.
Information on pregnancy outcomes and complications as well as fetal/neonatal/infant outcomes will be collected during the timeframe described in the protocol.
Subjects can enroll in the study by calling the telephone number directly (1-888-982-7299) or through SCYNEXIS BREXAFEMME Pregnancy Study Webpage, OR her healthcare provider (HCP) can, with her consent, enroll her on her behalf.
Data will be collected both retrospectively and prospectively using a variety of questionnaire that will be completed by the representative based on interview with the subject and/or HCP
109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.
This study's planned enrollment of 100 is below the median of 300 across 15 observational studies indexed under Candidiasis, Vulvovaginal.
Browse Candidiasis, Vulvovaginal studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Compared within Candidiasis, Vulvovaginal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vulvovaginitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
A self-reported pregnancy will be considered as confirmed pregnancy if the Urine Pregnancy Test (UPT) result is positive.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who have been treated with Brexafemme (Ibrexafungerp) at any time during pregnancy or whose conception is estimated to have occurred within four days after receiving the last dose of Brexafemme.
Other: Non-interventional study
This is not an interventional study
Major Structural Defects
To collect and describe selected fetal/neonatal/infant outcomes (i.e., major and minor congenital malformations, small for gestational age, and postnatal growth and development) at birth and through up to the first year of life of infants born to women exposed to ibrexafungerp during the defined pregnancy exposure window
Time frame: From Brexafemme exposure up to one year after birth
To collect and describe pregnancy outcomes
Live birth, spontaneous abortions, stillbirths, elective abortions, and preterm births
Time frame: From Brexafemme exposure up to one year post birth
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jul 2029, 44 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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