Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

Recruiting now

Conditions studied: Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis

In brief

This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.

Key facts

Study ID

NCT05908682

Run by

Scynexis, Inc.

People needed

100

Starts

2022-07-28

Expected to finish

2029-10-31

Last updated by the study team

2024-07-17

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Exposure to ibrexafungerp during pregnancy or if conception is estimated to have occurred within 4 days of the last dose of ibrexafungerp
• 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.

You may not qualify if…

• Females who were not exposed to safety study medications during pregnancy
• Refusal to participate in the study
• An inability to provide an accurate medical history or give informed consent

Where it is running

• AWINSA — New Delhi, Vasant Vihar, India (enrolling)

Full record on ClinicalTrials.gov

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