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Tests treatment safety and results for Vaginitis
Official title A Study of the Efficacy and Safety of WXSH0102 in Treating VCC Patients
ClinicalTrials.gov ID: NCT06771063
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64, women only. Healthy volunteers may be eligible.
You may be able to join if
- The people 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...
- people 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.
You likely can't join if
- Known or suspected allergic history to any component of this product, fluconazole or pyrrole drugs;
- people 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...
- 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;
See the full eligibility criteria
- The people 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...
- people 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.
- Known or suspected allergic history to any component of this product, fluconazole or pyrrole drugs;
- people 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.