Vulvovaginitis, CandidalNCT05908682
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
An observational study of Vulvovaginitis, Candidal and Vulvovaginal Candidiasis, run by GlaxoSmithKline at 1 site in India.
Trial summary
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age. Read more about this study
- Who is it for?
- Ages 0 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginitis, Candidal, Vulvovaginal Candidiasis, Candida Infection
- What is being tested?
- Non-interventional study
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 12 Nov 2025to 31 Jul 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
AWINSA
New Delhi, Vasant Vihar, 110057
Sanjeev Miglani, MD, +91-9910533655, sanjeev.miglani@awinsals.com
Sanjeev Miglani, MD
About this study
Official title: A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
Read the detailed description
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
- Conditions
- Vulvovaginitis, Candidal, Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis
- Being tested
- Non-interventional study
- Keywords
- VVC, Thrush, BREXAFEMME, Candidiasis, Vaginal Yeast, Yeast Infection
- Medical subject headings
- Vulvovaginitis, Candidiasis, Vulvovaginal, Candidiasis, Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
This is not an interventional study
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | 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. Receives: Other: Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Brexafemme exposure up to one year after birth
Secondary outcomes (1)
To collect and describe pregnancy outcomes
Live birth, spontaneous abortions, stillbirths, elective abortions, and preterm births
Measured: From Brexafemme exposure up to one year post birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start12 Nov 2025
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginitis, CandidalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908682
- Sponsor's protocol ID
- 222030
- Other IDs
- SCY-078-401
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
- ClinicalTrials.gov ID
- NCT05908682
- Acronym / sponsor ID
- 222030
- Conditions
- Vulvovaginitis, Candidal, Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis
- Keywords
- VVC, Thrush, BREXAFEMME, Candidiasis, Vaginal Yeast, Yeast Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
Detailed description
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
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: Non-interventional studySubjects 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. |
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional studyThis is not an interventional study | Other | Study Cohort |
Primary outcome
Major Structural Defects
Time frame: From Brexafemme exposure up to one year after birth
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
1 secondary outcome
To collect and describe pregnancy outcomes
Time frame: From Brexafemme exposure up to one year post birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvovaginitis, Candidal and Vulvovaginal Candidiasis, run by GlaxoSmithKline at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjeev Miglani, MD (+91-9910533655, sanjeev.miglani@awinsals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Structural Defects (time frame: From Brexafemme exposure up to one year after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.