Vulvovaginal CandidiasisVVCNCT07044947
Oteseconazole in the Treatment of Adults With Vulvovaginal Candidiasis（VVC）
An observational study of Vulvovaginal Candidiasis, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
Oteseconazole is a novel, oral, highly selective inhibitor of fungal CYP51. Oteseconazole showed statistically significant and clinically meaningful treatment of severe VVC and was generally tolerated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- Oteseconazole (VT-1161) 150mg capsule
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2025to 10 Aug 2030
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 3000
Who may be able to join
- ≥ 18 years old, female; vulvovaginal signs and symptoms (VSS) score ≥7; Plan to use oteseconazole monotherapy or combination therapy
Who cannot join
- Evidence has shown that the patient whohas been pregnant or lactating; Patients who are participating in or planning to participate in other interventional clinical studies; Other situations determined by the researcher as unsuitable for inclusion in the study
About this study
Official title: Non-interventional Real-World Study of Oteseconazole in the Treatment of Vulvovaginal Candidiasis
Oteseconazole is a novel, oral, highly selective inhibitor of fungal CYP51. Oteseconazole showed statistically significant and clinically meaningful treatment of severe VVC and was generally tolerated. The trial is a national multi-center, non-interventional observational real-world study, aiming to evaluate the effecacy and safety of oteseconazole in the treatment of patients with VVC. This study will include patients with severe vulvovaginal candidiasis (SVVC) . It is divided into prospective and retrospective parts.
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- Oteseconazole (VT-1161) 150mg capsule
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oteseconazole (VT-1161) 150mg capsuleDrug
Subjects with SVVC will be treated by Oteseconazole with 600 mg (150 mg per capsule) on D1, 450 mg on D2
| Study group | Role | What they receive |
|---|---|---|
| Oteseconazole | Subjects with SVVC will be treated with 600 mg (150 mg per capsule) on D1, 450 mg on D2 Receives: Drug: Oteseconazole (VT-1161) 150mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects achieving clinical cure at 6-month,
clinical cure，defined as the absence of signs and symptoms of VVC
Measured: 6-month after the end of treatment
Secondary outcomes (3)
The proportion of patients with clinical recurrence within 1-month, 12-month, 24-month and 36-month after treatment with Oteseconazole
Measured: 1-month, 12-month, 24-month and 36-month after the end of treatment
The time of the first clinical recurrence of VVC during the follow-up period
Measured: From enrollment to the end of treatment for 3 years"
Adverse events and serious adverse events from the time of signed consent to the end of the study
Measured: From enrollment to the end of treatment at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start10 Aug 2025 (estimated)
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe 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
- Other
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinping Liao, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044947
- Sponsor's protocol ID
- MA-VVC-RWS-002
- Acronym
- VVC
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Real-World Study of Oteseconazole in the Treatment of Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT07044947
- Acronym / sponsor ID
- VVC / MA-VVC-RWS-002
- Conditions
- Vulvovaginal Candidiasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Aug 2030 (estimated)
- First posted
- 1 Jul 2025 (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.
Oteseconazole is a novel, oral, highly selective inhibitor of fungal CYP51. Oteseconazole showed statistically significant and clinically meaningful treatment of severe VVC and was generally tolerated. The trial is a national multi-center, non-interventional observational real-world study, aiming to evaluate the effecacy and safety of oteseconazole in the treatment of patients with VVC. This study will include patients with severe vulvovaginal candidiasis (SVVC) . It is divided into prospective and retrospective parts.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oteseconazole | – | Drug: Oteseconazole (VT-1161) 150mg capsuleSubjects with SVVC will be treated with 600 mg (150 mg per capsule) on D1, 450 mg on D2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3000
Key inclusion criteria (1 listed)
- ≥ 18 years old, female; vulvovaginal signs and symptoms (VSS) score ≥7; Plan to use oteseconazole monotherapy or combination therapy
Key exclusion criteria (1 listed)
- Evidence has shown that the patient whohas been pregnant or lactating; Patients who are participating in or planning to participate in other interventional clinical studies; Other situations determined by the researcher as unsuitable for inclusion in the study
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 |
|---|---|---|
| Oteseconazole (VT-1161) 150mg capsuleSubjects with SVVC will be treated by Oteseconazole with 600 mg (150 mg per capsule) on D1, 450 mg on D2 | Drug | Oteseconazole |
Primary outcome
The proportion of subjects achieving clinical cure at 6-month,
Time frame: 6-month after the end of treatment
clinical cure，defined as the absence of signs and symptoms of VVC
3 secondary outcomes
The proportion of patients with clinical recurrence within 1-month, 12-month, 24-month and 36-month after treatment with Oteseconazole
Time frame: 1-month, 12-month, 24-month and 36-month after the end of treatment
The time of the first clinical recurrence of VVC during the follow-up period
Time frame: From enrollment to the end of treatment for 3 years"
Adverse events and serious adverse events from the time of signed consent to the end of the study
Time frame: From enrollment to the end of treatment at 3 years
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 1 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvovaginal Candidiasis, run by Beijing Tsinghua Chang Gung Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects achieving clinical cure at 6-month, (time frame: 6-month after the end of treatment). 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 1 Jul 2025.