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

Launched by CISEN PHARMACEUTICAL CO., LTD. · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying an experimental medication called WXSH0102 to see how effective and safe it is for treating a condition known as vulvovaginal candidiasis (VVC), which is a type of vaginal yeast infection. The trial involves four groups of female participants aged 18 to 64 who have been diagnosed with VVC. They will receive different doses of WXSH0102 or a standard treatment called fluconazole for one day. Participants will be monitored over a few weeks to see how well the medication works and if there are any side effects.

To be eligible for this study, women must be able to take the medication by mouth and agree to follow the study rules, including abstaining from sexual activity during the trial. They should also have specific symptoms and test results that confirm they have VVC. However, there are some reasons that might prevent someone from joining, such as allergies to the medications being tested or certain health conditions that could interfere with the results. Overall, this trial aims to find a better way to help women suffering from this uncomfortable condition.

Gender

FEMALE

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;