A multicenter, randomised, double- blind, between-patient, dose finding study to assess the safety, tolerability and efficacy of three different dosages (500, 1000 and 2000 mcg/g) of ABIO 12/01 gel, in comparison to an open active treatment, after a five-day vaginal administration to females with a confirmed clinical diagnosis of vulvovaginal candidiasis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001360-31-IT

Enrollment

200

Registered

2005-08-02

Start date

2005-07-04

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

VULVOVAGINAL CANDIDIASIS MedDRA version: 6.1 Level: PT Classification code 10046898

Interventions

Product Name: CKPV DIMER Product Code: ABIO12/01 Pharmaceutical Form: Vaginal gel Current Sponsor code: ABIO 12/01 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026