Actively Recruiting
A Study of the Efficacy and Safety of WXSH0102 in Treating VCC Patients
Led by Cisen Pharmaceutical CO., LTD. · Updated on 2025-02-13
108
Participants Needed
2
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of the Efficacy and Safety of WXSH0102 in Treating VCC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 64 years who have had sexual intercourse
- Diagnosed with vulvovaginal candidiasis with a VVC scale score of 4 or higher and at least two symptoms or signs
- Vaginal discharge sample positive for Candida by Gram stain at screening
- Vaginal pH of 4.5 or lower
- Symptoms include vulvovaginal itching, vulvar burning pain, pain during sex and urination, excessive secretion resembling tofu residue
- Physical signs include vulvar redness and swelling, possible scratches, chapped skin, exfoliation, erosion, and hyperemic vaginal mucosa with curd-like secretions
- Able to take medication orally
- Agree to abstain from sexual activity or use condoms throughout the study period
You will not qualify if you...
- Allergic history to components of the study drug, fluconazole, or pyrrole drugs
- Any vulvovaginal or cervical disease affecting diagnosis or evaluation of VVC
- Use of topical or systemic antifungal treatments for VVC within 14 days before randomization
- Significant liver disease or abnormal liver function tests (ALT or AST above 1.5 times the upper limit of normal)
- Severe kidney disease or renal insufficiency (GFR less than 60 ml/min/1.73m2)
- Planned treatment or surgery for vulvar, vaginal, or cervical lesions during the study
- Severe gastrointestinal disease or conditions affecting drug absorption
- Severe dysfunction of heart, lung, liver, kidney, or blood-forming systems
AI-Screening
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Trial Site Locations
Total: 2 locations
1
251 Yaojiayuan Road, Chaoyang District, Beijing
Beijing, Beijing Municipality, China, 100025
Not Yet Recruiting
2
Beijing Obstetrics and Gynecology Hospital
Beijing, Beijing Municipality, China, 100025
Actively Recruiting
Research Team
Z
Zhaohui Liu, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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