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A Study of the Efficacy and Safety of WXSH0102 in Treating VCC Patients

ConditionVaginitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-64
SponsorCisen Pharmaceutical CO., LTD.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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 );

Trial design

Design model

Parallel

Treatments tested in this trial

  • WXSH0102/placebo

    Drug

    Administer WXSH0102 tablets/placebo orally.

  • fluconazole capsules/placebo

    Drug

    Administer fluconazole capsules/placebo orally

Treatment groups

108 Participants
are divided into 4 treatment groups
Group A: Arm A : WXSH0102 Day1 1400 mg Day2-3 700Experimental treatment 1 intervention
Group B: Arm B : WXSH0102 Day1 1000 mg Day2-3 500 armExperimental treatment 1 intervention
Group C: C : WXSH0102 Day1 600 mg Day2-3 300Experimental treatment 1 intervention
Group D: Arm D: fluconazoleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cisen Pharmaceutical CO., LTD.

Lead sponsor

Source ClinicalTrials.gov
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