Evaluating WXSH0102 for treating vulvovaginal candidiasis

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 testing a new drug called WXSH0102 to see if it can effectively treat vulvovaginal candidiasis and comparing it to a standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 64 Years
• Sex: Female
• Sponsor: Cisen Pharmaceutical CO., LTD. (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06771063 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial aims to assess the efficacy and safety of the investigational drug WXSH0102 in treating vulvovaginal candidiasis (VVC). Participants will be randomly assigned to one of four groups: three groups receiving different dosing regimens of WXSH0102 and one group receiving an active control, fluconazole. The trial includes a screening/enrollment phase, a treatment period, and a follow-up period to monitor outcomes. The study will evaluate symptom relief and safety profiles associated with the different dosing strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 18-64 who have been diagnosed with vulvovaginal candidiasis and meet specific clinical criteria.

Not a fit: Patients who do not have a confirmed diagnosis of vulvovaginal candidiasis or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from vulvovaginal candidiasis.

How similar studies have performed: While there have been studies on treatments for vulvovaginal candidiasis, the specific approach and drug being tested in this trial may offer novel insights into treatment efficacy.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• 251 Yaojiayuan Road, Chaoyang District, Beijing — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Obstetrics and Gynecology Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhaohui Liu, professor

Conditions Vaginitis