Evaluating WXSH0102 for treating vulvovaginal candidiasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Obstetrics and Gynecology Hospital
  Beijing, Beijing Municipality, China Recruiting
• 251 Yaojiayuan Road, Chaoyang District, Beijing
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Zhaohui Liu, professor
• Email: 23662161@qq.com
• Phone: 13701118639

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vaginitis Diagnostic Algorithm Pilot Using Nanopath and Other Tests

  This study tests a new Nanopath vaginal test to see if it correctly detects vaginitis-causing pathogens in up to 1,000 people with vaginitis symptoms.

  Recruiting at 2 sites Nanopath, Inc · North Miami, Florida and 1 other locations · NCT07607470

• Evaluating vulvovaginitis effects on surgical outcomes after vulvar excision

  This study is testing how common vulvovaginitis is in women having surgery for non-cancerous vulvar conditions and whether it affects their recovery.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT06070454

• Treatment for aerobic vaginitis using Baofukang vaginal suppository

  This study tests if a new vaginal suppository can help women with aerobic vaginitis feel better, comparing two different treatment lengths of 7 days and 14 days.

  Recruiting Phase 3 Peking University Shenzhen Hospital · Shenzhen, Guangdong · NCT04574089

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.