Treatment of infectious diseases and disorders affecting the female sex organs;
- Conditions
- ncomplicated vulvovaginal candidosis (VVC)MedDRA version: 20.0Level: LLTClassification code 10047783Term: Vulvovaginal candidaSystem Organ Class: 100000054373Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2016-002808-19-PL
- Lead Sponsor
- Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 440
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
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
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 condom 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.
11. Patients suffering from chronic/recurrent vulvovaginal mycosis, defined as four or more mycological proven symptomatic episodes during the last 12 months.
12. Inability to comply with the protocol requirements, instructions or study-related restrictions (i.e. uncooperative attitude, inability to return for study visits, unlikelihood of completing the clinical study).
13. Vulnerable patients (i.e. persons kept in detention).
14. Subjects involved in the conduct of the study (i.e. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel).
15. Participation to an interventional clinical trial within 3 months prior to Visit 0.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method