VaginitisPhase 2NCT06771063
A Study of the Efficacy and Safety of WXSH0102 in Treating VCC Patients
A Phase 2 study of Vaginitis, run by Cisen Pharmaceutical CO., LTD. at 2 sites in China.
Trial summary
This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesChina
- Study dates
- 13 Jan 2025to 31 Jul 2025
- Phase
- Phase 2
- 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 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects understood and voluntarily signed the informed consent Form (ICF), and were willing and able to comply with the study protocol.
- Female participants who signed ICF at the age of 18-64 years (including the cut-off value) and had sexual intercourse;
- Participants were diagnosed with VVC and met each of the following criteria: a. At screening, the total score on the VVC scale was ≥4 and at least two of the symptoms or signs on the VVC scale were present; b. A vaginal discharge sample collected at screening was Gram stain positive for Candida (hypha/pseudohypha/budding); c. Vaginal pH ≤4.5; Symptoms: vulvovaginal itching, vulvar burning pain, dyspareunia and urination pain, excessive secretion, secretion is tofu residue like; Physical signs: gynecological examination showed vulvar hyperemia and edema, which may be accompanied by scratches. In severe cases, chapped skin, exfoliation and even erosion could be seen. Vaginal mucosa was hyperemic, vaginal secretion was curd or tofu residue like;
- Subjects who are capable of oral administration;
- For the duration of the study, participants agreed to abstain from sexual activity and to use the condom throughout sexual activity.
Who cannot join
- Known or suspected allergic history to any component of this product, fluconazole or pyrrole drugs;
- Subjects with any vulvovaginal or cervical disease that may affect the diagnosis and evaluation of VVC;
- Topical or systemic antifungal treatment for VVC within 14 days before randomization;
- Significant liver disease or abnormal liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST] > 1.5 ULN); Patients with severe renal disease or renal insufficiency (glomerular filtration rate (GFR) < 60ml/min/1.73m2 );
- Patients who planned to undergo treatment or surgery for vulvar, vaginal or cervical lesions during the study period;
- Severe gastrointestinal disease or other conditions that may affect the absorption of the trial drug;
- Patients with severe heart, lung, liver, kidney dysfunction and hematopoietic system diseases;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
251 Yaojiayuan Road, Chaoyang District, Beijing
Beijing, Beijing Municipality, 100025
zhaohui liu, professor, 13701118639, 23662161@qq.com
- Recruiting
Beijing Obstetrics and Gynecology Hospital
Beijing, Beijing Municipality, 100025
hui zhao liu, 13701118639, 23662161@qq.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of WXSH0102 Tablets in the Treatment of Vulvovaginal Candidiasis (VVC)
This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. The trial consists of three phases: screening/enrollment (D-3 to D-1), treatment period (D1 to D3), and follow-up period (D4, D11±2, D25±3). Eligible subjects in this study will be randomized in a 1:1:1:1 ratio to three investigational drug arms with different dosing regimens and one active control arm. Specifically, Group A will receive WXSH0102 tablets with 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days, Group B will receive WXSH0102 tablets with 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days, Group C will receive WXSH0102 tablets with 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days, and Group D (active control group) will receive fluconazole capsules for only one day on D1. All medications will be administered orally.
- Conditions
- Vaginitis
- Being tested
- WXSH0102/placebo, fluconazole capsules/placebo
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WXSH0102/placeboDrug
Administer WXSH0102 tablets/placebo orally.
fluconazole capsules/placeboDrug
Administer fluconazole capsules/placebo orally
| Study group | Role | What they receive |
|---|---|---|
| Arm A : WXSH0102 Day1 1400 mg Day2-3 700 | Experimental | Arm A will receive WXSH0102 tablets with a loading dose of 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days Receives: Drug: WXSH0102/placebo |
| Arm B : WXSH0102 Day1 1000 mg Day2-3 500 arm | Experimental | Arm B will receive WXSH0102 tablets with a loading dose of 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days Receives: Drug: WXSH0102/placebo |
| C : WXSH0102 Day1 600 mg Day2-3 300 | Experimental | Arm C will receive WXSH0102 tablets with a loading dose of 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days Receives: Drug: WXSH0102/placebo |
| Arm D: fluconazole | Active comparator | Arm D (active control group) will receive fluconazole capsules for only one day on D1 Receives: Drug: fluconazole capsules/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving cure at the D11±2 visit.
Proportion of subjects achieving cure (defined as the disappearance of VVC symptoms and signs along with a negative Candida culture) at the D11±2 visit.
Measured: day 11±2
Secondary outcomes (12)
Proportion of subjects achieving clinical cure at the D11±2 visit
Proportion of subjects achieving clinical cure (complete disappearance of VVC symptoms and signs) at the D11±2 visit;
Measured: day 11±2
Proportion of subjects achieving mycological clearance at the D11±2 visit
Proportion of subjects achieving mycological clearance (negative growth of Candida species in fungal culture) at the D11±2 visit;
Measured: day 11±2
Proportion of subjects achieving clinical improvement at the D11±2 visit
Proportion of subjects achieving clinical improvement (partial or complete resolution of symptoms and signs, with a total VVC scale score ≤1) at the D11±2 visit
Measured: day 11±2
Difference in VVC scale scores between the D11±2 visit and baseline visit
Difference in VVC scale scores between the D11±2 visit and baseline visit
Measured: day 11±2
Proportion of subjects achieving cure at the D25±3 visit.
Proportion of subjects achieving cure (defined as the disappearance of VVC symptoms and signs along with a negative Candida culture) at the D25±3 visit..
Measured: Day 25±3
Proportion of subjects achieving mycological clearance at the D25±3 visit
Description: Proportion of subjects achieving mycological clearance (negative growth of Candida species in fungal culture) at the D25±3 visit;
Measured: Day 25±3
Proportion of subjects achieving clinical improvement at the D25±3 visit
Description: Proportion of subjects achieving clinical improvement (partial or complete resolution of symptoms and signs, with a total VVC scale score ≤1) at the D25±3visit
Measured: Day 25±3
Proportion of subjects requiring rescue therapy during the trial;
Proportion of subjects requiring rescue therapy during the trial;
Measured: Day 25±3
Proportion of subjects with normal vaginal microecology assessments
Proportion of subjects with normal vaginal microecology assessments at the D11±2 and D25±3 visits
Measured: Day11±2 and day 25±3
adverse events
Incidence and severity of adverse events and serious adverse events
Measured: Day 25±3
AUC0-tau
the AUC0-tau estimated using non-compartmental and/or population pharmacokinetic models
Measured: day 4
Cmax
the Cmax estimated using non-compartmental and/or population pharmacokinetic models
Measured: day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start13 Jan 2025
- Primary completion10 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cisen Pharmaceutical CO., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771063
- Sponsor's protocol ID
- WXSH0102-02-001
- Status last verified
- Feb 2025
- First submitted
- 25 Dec 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of WXSH0102 Tablets in the Treatment of Vulvovaginal Candidiasis (VVC)
- ClinicalTrials.gov ID
- NCT06771063
- Acronym / sponsor ID
- WXSH0102-02-001
- Conditions
- Vaginitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Cisen Pharmaceutical CO., LTD.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 13 Jan 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.
This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. The trial consists of three phases: screening/enrollment (D-3 to D-1), treatment period (D1 to D3), and follow-up period (D4, D11±2, D25±3). Eligible subjects in this study will be randomized in a 1:1:1:1 ratio to three investigational drug arms with different dosing regimens and one active control arm. Specifically, Group A will receive WXSH0102 tablets with 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days, Group B will receive WXSH0102 tablets with 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days, Group C will receive WXSH0102 tablets with 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days, and Group D (active control group) will receive fluconazole capsules for only one day on D1. All medications will be administered orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A : WXSH0102 Day1 1400 mg Day2-3 700 | Experimental | Drug: WXSH0102/placeboArm A will receive WXSH0102 tablets with a loading dose of 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days |
| Arm B : WXSH0102 Day1 1000 mg Day2-3 500 arm | Experimental | Drug: WXSH0102/placeboArm B will receive WXSH0102 tablets with a loading dose of 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days |
| C : WXSH0102 Day1 600 mg Day2-3 300 | Experimental | Drug: WXSH0102/placeboArm C will receive WXSH0102 tablets with a loading dose of 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days |
| Arm D: fluconazole | Active comparator | Drug: fluconazole capsules/placeboArm D (active control group) will receive fluconazole capsules for only one day on D1 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subjects understood and voluntarily signed the informed consent Form (ICF), and were willing and able to comply with the study protocol.
- Female participants who signed ICF at the age of 18-64 years (including the cut-off value) and had sexual intercourse;
- Participants were diagnosed with VVC and met each of the following criteria: a. At screening, the total score on the VVC scale was ≥4 and at least two of the symptoms or signs on the VVC scale were present; b. A vaginal discharge sample collected at screening was Gram stain positive for Candida (hypha/pseudohypha/budding); c. Vaginal pH ≤4.5; Symptoms: vulvovaginal itching, vulvar burning pain, dyspareunia and urination pain, excessive secretion, secretion is tofu residue like; Physical signs: gynecological examination showed vulvar hyperemia and edema, which may be accompanied by scratches. In severe cases, chapped skin, exfoliation and even erosion could be seen. Vaginal mucosa was hyperemic, vaginal secretion was curd or tofu residue like;
- Subjects who are capable of oral administration;
- For the duration of the study, participants agreed to abstain from sexual activity and to use the condom throughout sexual activity.
Key exclusion criteria (7 listed)
- Known or suspected allergic history to any component of this product, fluconazole or pyrrole drugs;
- Subjects with any vulvovaginal or cervical disease that may affect the diagnosis and evaluation of VVC;
- Topical or systemic antifungal treatment for VVC within 14 days before randomization;
- Significant liver disease or abnormal liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST] > 1.5 ULN); Patients with severe renal disease or renal insufficiency (glomerular filtration rate (GFR) < 60ml/min/1.73m2 );
- Patients who planned to undergo treatment or surgery for vulvar, vaginal or cervical lesions during the study period;
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 |
|---|---|---|
| WXSH0102/placeboAdminister WXSH0102 tablets/placebo orally. | Drug | Arm A : WXSH0102 Day1 1400 mg Day2-3 700, Arm B : WXSH0102 Day1 1000 mg Day2-3 500 arm, C : WXSH0102 Day1 600 mg Day2-3 300 |
| fluconazole capsules/placeboAdminister fluconazole capsules/placebo orally | Drug | Arm D: fluconazole |
Primary outcome
Proportion of subjects achieving cure at the D11±2 visit.
Time frame: day 11±2
Proportion of subjects achieving cure (defined as the disappearance of VVC symptoms and signs along with a negative Candida culture) at the D11±2 visit.
12 secondary outcomes
Proportion of subjects achieving clinical cure at the D11±2 visit
Time frame: day 11±2
Proportion of subjects achieving mycological clearance at the D11±2 visit
Time frame: day 11±2
Proportion of subjects achieving clinical improvement at the D11±2 visit
Time frame: day 11±2
Difference in VVC scale scores between the D11±2 visit and baseline visit
Time frame: day 11±2
Proportion of subjects achieving cure at the D25±3 visit.
Time frame: Day 25±3
Proportion of subjects achieving mycological clearance at the D25±3 visit
Time frame: Day 25±3
Proportion of subjects achieving clinical improvement at the D25±3 visit
Time frame: Day 25±3
Proportion of subjects requiring rescue therapy during the trial;
Time frame: Day 25±3
Proportion of subjects with normal vaginal microecology assessments
Time frame: Day11±2 and day 25±3
adverse events
Time frame: Day 25±3
AUC0-tau
Time frame: day 4
Cmax
Time frame: day 4
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 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Vaginitis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Vaginitis, run by Cisen Pharmaceutical CO., LTD. at 2 sites in China.
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 7 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhaohui Liu, professor (13701118639, 23662161@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving cure at the D11±2 visit. (time frame: day 11±2). 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 13 Feb 2025.