Trials Sponsors Conditions Drugs Pricing

Conditions

Acute vulvovaginal candidiasis

Outcome Measures

Primary Outcomes (1)

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

Interventions

Diflucan 150 mg cápsulas duras.Type not reported

AlbaconazoleType not reported

Albaconazole

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Albaconazole
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry record
Formulated product
Albaconazole
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry record
Formulated product
Albaconazole
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Albaconazole
Named ingredient: albaconazole
View registry record
Albaconazole
Named ingredient: albaconazole
View registry record
Albaconazole
Named ingredient: albaconazole
View registry record

Eligibility Criteria

Sexfemale

Age GroupsAdult (18-64), Child (0-17), Older Adult (65+)

You may qualify if:

Female post-menarche subjects
Diagnosed with acute Candida vulvovaginitis according to the following criteria: a. Two or more of the signs and symptoms of Candida vulvovaginitis (itching, burning, irritation, oedema, redness, or excoriation), with at least one with moderate intensity of vulvovaginal signs and symptoms Grade of symptoms is defined as follows: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. b. Rapid antigen test positive for Candida spp. c. Vaginal pH ≤ 4.4 The diagnosis must be confirmed by a positive Candida spp. culture. Swabs for the culture have to be taken before the intake of IP.

Sponsors & Collaborators

Palau Pharma S.L.
Industrylead

Study Sites (26)

Salve Medica Sp. z o.o. S.K.

Lodz, 91-211, Poland

Bogna Sobkiewicz+48422546400 b.sobkiewicz@salvemedica.pl

Gyncentrum Sp. z o.o.

Katowice, 40-851, Poland

Dariusz Mercik+48601874847 d.mercik@gyncentrum.pl

Gyncentrum Sp. z o.o.

Czestochowa, 42-218, Poland

Alicja Gajewska-Kucharek+48516106618

Central Study Contacts

DCALB Information Desk

+34937376690 regulatory@noucor.com

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

May 31, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-504727-32-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 03:40:34 UTC

Documents

K1_Recruitment arrangements_public

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations