A Phase 2 interventional study of WXSH0102/placebo and fluconazole capsules/placebo in Vaginitis, sponsored by Cisen Pharmaceutical CO., LTD.. Recruiting at 2 sites in China. Open to female participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Cisen Pharmaceutical CO., LTD. · Phase 2, Interventional, and Treatment
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.
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's planned enrollment of 108 is close to the median of 108 across 71 interventional studies indexed under Vaginitis.
Browse Vaginitis studies →This is the only study on the registry with Cisen Pharmaceutical CO., LTD. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: WXSH0102/placebo
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
Drug: WXSH0102/placebo
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
Drug: WXSH0102/placebo
Arm D (active control group) will receive fluconazole capsules for only one day on D1
Drug: fluconazole capsules/placebo
Administer WXSH0102 tablets/placebo orally.
Administer fluconazole capsules/placebo orally
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.
Time frame: day 11±2
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;
Time frame: 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;
Time frame: 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
Time frame: 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
Time frame: 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..
Time frame: 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;
Time frame: 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
Time frame: Day 25±3
Proportion of subjects requiring rescue therapy during the trial;
Proportion of subjects requiring rescue therapy during the trial;
Time frame: 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
Time frame: Day11±2 and day 25±3
adverse events
Incidence and severity of adverse events and serious adverse events
Time frame: Day 25±3
AUC0-tau
the AUC0-tau estimated using non-compartmental and/or population pharmacokinetic models
Time frame: day 4
Cmax
the Cmax estimated using non-compartmental and/or population pharmacokinetic models
Time frame: day 4
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Jul 2025, 5 months after the start.
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