None listed
Conditions
Brief summary
Patients with a diagnosis of chronic vulvovaginal candidiasis will be identified through the vulval dermatology clinic at Royal North Shore Hospital. Those who fulfill all inclusion criteria and no exclusion criteria will be invited to take part in the study. Once informed consent has been obtained, a visual analogue scale (VAS) of the patient’s CVVC will be performed, as well as a low vaginal swab and baseline blood tests (full blood count, electrolytes/urea/creatinine, liver function tests). Patients will also be asked to complete a Dermatology Life Quality Index (DLQI) questionnaire. If the blood tests return within normal limits, the patient may commence the study. Patients will be randomized into one of two groups: Group A will take one 50mg fluconazole capsule daily, and Group B will take one 150mg capsule weekly with placebo capsules on the other days. Patients will return after 6 weeks and the VAS and DLQI will be repeated. After another 6 weeks, the VAS, DLQI and the blood tests will be repeated. Those who have had significant improvement may continue in the open-label extension and be treated with one 50mg tablet twice per week. Those who have not improved will undergo further investigation within the vulval dermatology clinic. At each visit, patients will be asked about any potential side-effects or adverse events.
Interventions
Intervention:
Patients aged 18 years or older with chronic vulvovaginal candidiasis (as diagnosed using validated diagnostic criteria) will be recruited for the study through the vulval dermatology clinical at Royal North Shore Hospital. Patients will initially undergo clinical examination, low vaginal swab, and baseline blood tests (full blood count, electrolytes/urea/creatinine, and liver function tests). If the blood tests return normal, subjects will be randomised by an independent investig
Intervention: Patients aged 18 years or older with chronic vulvovaginal candidiasis (as diagnosed using validated diagnostic criteria) will be recruited for the study through the vulval dermatology clinical at Royal North Shore Hospital. Patients will initially undergo clinical examination, low vaginal swab, and baseline blood tests (full blood count, electrolytes/urea/creatinine, and liver function tests). If the blood tests return normal, subjects will be randomised by an independent investigator into one of two groups. Intervention group will receive treatment of fluconazole 50mg orally daily for 12 weeks. Patients will complete a questionnaire grading their symptoms and objective signs (erythema, oedema, fissuring, distribution, discharge) will be assessed by 2 independent blinded doctors. Date of menstrual cycle will be recorded. Patients will be reviewed at 6 weeks of treatment. Response to treatment will be re-assessed using the same criteria. At week 12, all patients will undergo repeat clinical examination, questionnaire and blood tests. Those whose symptoms have resolved may continue on 50mg fluconazole twice per week, as an ongoing maintenance dose. These patients will be reassessed using all criteria at 3, 6 and 12 months follow up. The strategy used to monitor adherence to the intervention will be counting and documenting patient's drug tablet return.
Sponsors
Royal North Shore Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Female 18 years and older Premenopausal Chronic vulvovaginal candidiasis as per diagnostic criteria* Willingness to give written informed consent and willingness to participate and comply with the study The diagnostic criteria established are: Diagnostic: One major + 5 minor criteria Presumptive: One major + 3-4 minor criteria Major Criterion: - Chronic non-erosive, nonspecific vulvovaginitis Minor Criteria: - Positive vaginal swab either on presentation or in the past - Soreness - Cyclicity - Dyspareunia - Previous response to antifungal therapy (even if incomplete) - Exacerbation with antibiotics - Swelling - Discharge
Exclusion criteria
Patients who are pregnant, lactating, or who are planning to become pregnant Patients with a history of hypersensitivity to fluconazole Patients with severe renal dysfunction Patients with liver disease Patients who are clinically menopausal
Outcome results
None listed