A double-blind, randomised, dose-finding trial to assess the efficacy, safety and pharmacokinetics of a single dose of albaconazole versus fluconazole and placebo in the treatment of acute Candida vulvovaginitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504727-32-00

Acronym

DC13ALB/2/21

Enrollment

702

Registered

2023-09-18

Start date

2023-09-18

Completion date

2025-10-28

Last updated

2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute vulvovaginal candidiasis

Brief summary

Percentage of subjects with clinical cure defined as vulvovaginal score sum = 0 at the Final Visit (FV) by treatment group (albaconazole vs. placebo).

Interventions

DRUGDiflucan 150 mg cápsulas duras.

DRUGAlbaconazole

DRUGPlacebo - Albaconazole

DRUGPlacebo - Fluconazole

DRUGCANADIOL 100 mg cápsulas

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with clinical cure defined as vulvovaginal score sum = 0 at the Final Visit (FV) by treatment group (albaconazole vs. placebo).	—

Countries

Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026