Phase III study to evaluate the efficacy of a novel antimycotic vaginal pessary combination (containing Benzydamine HCl 6 mg and Econazole nitrate 150 mg) in the Treatment of uncomplicated vulvovaginal candidosis (VVC) [BEtreat study] - BEtreat study

AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.0 sites440 target enrollmentAugust 1, 2018

Overview

No summary available.

Registry

who.int

Start Date

August 1, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.

•1\. Females between 18 and 65 years of age (limits included), with no limitation of race.
•2\. Patients clinically diagnosed with uncomplicated VVC, as confirmed by a positive vaginal wet mount test.
•3\. Patients presenting at baseline a total score \= 3 in the subjective symptoms and a total score \= 1 in the objective signs.
•4\. Female of childbearing potential must have a negative pregnancy test at Visit 0 and agree to refrain from sexual intercourse from the signature of the informed consent up to Visit 4\.
•5\. Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 380
•F.1\.3 Elderly (\>\=65 years) yes

•1\. Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications.
•2\. Lactating women.
•3\. Patients suffering from vaginitis of different etiology.
•4\. Treatment with systemic antifungal drugs within 4 weeks or with topical antifungal drugs within 1 week before Visit 0\.
•5\. Use of any topical drugs on the application area and systemic drugs, including over the counter, oral anticoagulants (i.e. warfarin or acenocoumarol), anti\-inflammatory and/or analgesic drugs, antibiotics
•or antibacterials, within 2 weeks before Visit 0\. Hormonal contraceptives and hormonal replacement therapies are allowed.
•6\. Patients with actual menstruation at Visit 0 or expected menstruation within 11 days after Visit 0\.
•7\. Clinically significant abnormalities at physical examination, vital signs, ECG, laboratory tests at Visit 0\.
•8\. Patients suffering from gynecological diseases (genital tract abnormalities, lichen sclerosus, post\-operative alterations of the genital
•tract, genital tract neoplasm) that may interfere with the study endpoints and/or procedures.