Recurrent Vulvovaginal Candidiasis
Conditions
Interventions
Menstrual Cycle-Related Prophylactic Vaginal Medication Group:Menstrual Cycle-Related Prophylactic Vaginal Medication
Conventional As-Needed Treatment Group:Conventional As-Needed Treatment
Sponsors
Hefei First People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-55 years old; 2. Female; 3. Not pregnant or lactating; 4. Meet the definition of recurrent vulvovaginal candidiasis, that is, have experienced more than or equal to 3 episodes of symptomatic vulvovaginal candidiasis within the past 12 months; 5. This visit meets the clinical diagnosis of vulvovaginal candidiasis, presenting with one or more symptoms such as vulvar pruritus, burning pain, pain, and abnormal vaginal discharge. Gynecological examination suggests manifestations of vulvovaginal inflammation or soybean dred-like discharge. 6. Vaginal discharge examination reveals spores and/or fungi (+); 7. There is a relatively fixed relationship between previous relapses and the menstrual cycle, that is, at least two of the past three VVC episodes occurred in similar menstrual cycle Windows, such as within 7 days before menstruation, within 7 days after menstruation ends, or other fixed cycle stages that the patient can clearly recall/record. 8. The menstrual cycle is relatively regular, and it can be used to record the time of menstruation, changes in symptoms and medication usage. 9. Be willing to accept the initial treatment, randomization, follow-up and related examinations as stipulated in the study; 10. Voluntarily participate in this study and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Planning to become pregnant during the study follow-up period; 3.Postmenopausal, amenorrheic, or having significantly irregular menstrual cycles, making it difficult to identify menstrual cycle-related recurrence windows; 4.Diagnosed with significant bacterial vaginosis, trichomoniasis, gonorrhea, chlamydia infection, active genital herpes, or other reproductive tract infections requiring special treatment; 5.Complicated with severe vulvar skin conditions, such as contact dermatitis, vulvar eczema, vulvar leukoplakia, or other diseases that may interfere with symptom assessment; 6.Poorly controlled diabetes, long-term use of immunosuppressants, undergoing treatment for malignant tumors, or other conditions with significant immunosuppression; 7.Severe hepatic or renal dysfunction, or deemed unsuitable for fluconazole treatment by the investigator; 8.Known allergy to miconazole nitrate, fluconazole, or other azole antifungal medications; 9.Use of systemic or vaginal antifungal medications within the past 2 weeks that may affect the evaluation of the initial treatment outcome; 10.Any other conditions deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of VVC Recurrences; | — |
Secondary
| Measure | Time frame |
|---|---|
| VVC Recurrence Rate Within Three Months;Patient Compliance and Satisfaction;Changes in Symptom Scores for Vulvar Itching, Burning, Pain, and Abnormal Discharge;Antifungal Medication Usage Within Six Months;At Least One VVC Recurrence Confirmed by Symptoms and Microscopy Within Six Months;Number of Outpatient Visits Due to VVC Within Six Months;Usage of Nifuratel or Other Rescue Treatments;Time to First VVC Recurrence;Incidence of Treatment-Related Adverse Reactions; | — |
Countries
China
Contacts
Public ContactDing Boyang
Hefei First People's Hospital
Outcome results
None listed