Treatment of infectious diseases and disorders affecting the female sex organs.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 440

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 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
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

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.
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

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