A randomized, double-blinded study investigating the safety and efficacy of daily low-dose oral fluconazole versus weekly fluconazole in the treatment of chronic vulvovaginal candidiasis

Phase 4

Terminated

Conditions: Chronic vulvovaginal candidiasis
Skin - Dermatological conditions
Infection - Other infectious diseases
Renal and Urogenital - Other renal and urogenital disorders

Registration Number: ACTRN12614001258640

Lead Sponsor: Royal North Shore Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Stopped early

Sex: Female

Target Recruitment: 200

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of chronic vulvovaginal candidiasis symptoms.<br>This will be assessed by patients completing a questionnaire (including Dermatology Life Quality Index) 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. [6 weeks ];Presence of chronic vulvovaginal candidiasis symptoms.<br>This will be assessed by patients completing a questionnaire (including Dermatology Life Quality Index) 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. [12 weeks]

Secondary Outcome Measures

Name	Time	Method
Presence of chronic vulvovaginal candidiasis symptoms.<br>This will be assessed by patients completing a questionnaire (including Dermatology Life Quality Index) 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. [12 months];Presence of deranged Liver Function Tests (LFT) after treatment with fluconazole[12 weeks]