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

A.C.R.A.F. S.p.A. (Aziende Chimiche Riunite Angelini Francesco)0 sites445 target enrollmentJuly 3, 2017

Conditionsncomplicated vulvovaginal candidosis (VVC)MedDRA version: 20.0 Level: LLT Classification code 10047783 Term: Vulvovaginal candida System Organ Class: 100000054373 Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

DrugsPevaryl® 150 mg vaginal pessary

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ncomplicated vulvovaginal candidosis (VVC)
Sponsor: A.C.R.A.F. S.p.A. (Aziende Chimiche Riunite Angelini Francesco)
Enrollment: 445
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 3, 2017

End Date

April 2, 2018

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

A.C.R.A.F. S.p.A. (Aziende Chimiche Riunite Angelini Francesco)

Eligibility Criteria

Inclusion Criteria

•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 and women in a postmenopausal state. Females of childbearing potential and women with no menses for a period \< 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to Visit 4, using an appropriate birth control method such as combined estrogen\-progestin containing hormonal contraceptives (e.g. oral, transdermal), progestin\-only hormonal contraceptives (e.g. oral, injectable, implantable), intrauterine device (IUD) or intrauterine hormone\-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
•Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post\-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
•A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
•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:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•1\. Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications.
•2\. Lactating and pregnant women.
•3\. Patients suffering from vaginitis of different etiology, bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papilloma virus, according to the medical history, physical and gynecological examination
•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\. Intravaginal hormonal contraceptives and male condoms are not 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 end\-points and/or procedures.
•9\. Immunocompromised patients or patients affected by non\-controlled diabetes, or patients being treated with drugs (e.g. immunosuppressants, corticosteroids, anti\-infectives), which may predispose to mycological infections.
•10\. Signs or symptoms or clinical documentation for concurrent infections (including but not limited to sexually transmitted infections) and/or neoplasm.