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Clinical Trials/ACTRN12614001258640
ACTRN12614001258640
Terminated
Phase 4

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

Royal North Shore Hospital0 sites200 target enrollmentDecember 2, 2014
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ConditionsChronic vulvovaginal candidiasisSkin - Dermatological conditionsInfection - Other infectious diseasesRenal and Urogenital - Other renal and urogenital disorders

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Chronic vulvovaginal candidiasis
Sponsor
Royal North Shore Hospital
Enrollment
200
Status
Terminated
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 2, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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:

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

Outcomes

Primary Outcomes

Not specified

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