Uncomplicated vulvovaginal candidosis (VVC) MedDRA version: 20.0 Level: LLT Classification code 10047783 Term: Vulvovaginal candida System Organ Class: 100000054373
Conditions
Interventions
Product Name: benzydamine HCl and econazole nitrate
Pharmaceutical Form: Pessary
INN or Proposed INN: Benzydamine
CAS Number: 132-69-4
Current Sponsor code: 030(4C)
Other descriptive name: BENZYDAMIN
Sponsors
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the microbiological and clinical efficacy, the safety and acceptability of the benzydamine HCl 6 mg and econazole nitrate 150 mg vaginal pessary, in comparison to Pevaryl® 150 mg vaginal pessary, in the treatment of uncomplicated VVC.;Secondary Objective: Not applicable;Primary end point(s): Co-primary end-points: microbiological and clinical efficacy of the benzydamine HCl 6 mg and econazole nitrate 150 mg vaginal pessary vs Pevaryl® 150 mg vaginal pessary. · First co-primary end-point: the microbiological response, defined as the absence of Candida or other yeasts at microscopy (mycological cure) at Visit 3, or at Visit 4. · Second co-primary end-point: the clinical response, in terms of the time to first relief of symptoms, defined as the earliest time when the sum of the scores for all symptoms declines by 1 point or more with respect to the sum of the scores at baseline.;Timepoint(s) of evaluation of this end point: The first co-primary endpoint will be evaluated at Visit 3, or at Visit 4. The second co-primary endpoint will be evaluated up to Visit 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-points will be the comparison between the two treatment groups about: · the time to total symptoms relief, defined as the time when the sum of the scores for all symptoms becomes 0; · the clinical response, in terms of percent change of the sum of the scores for all symptoms from baseline at each time point up to Visit 1 (at 24h after the first drug administration), or at ETTV/ETV; · the clinical efficacy, in terms of clinical cure, defined as resolution of all signs and symptoms (total score=0), assessed at Visit 3, or at ETTV/ETV; · the clinical efficacy, in terms of clinical improvement, defined as decrease from baseline of the total score of signs and symptoms =50%), assessed at Visit 3, or at ETTV/ETV; · the clinical efficacy in terms of clinical failure, defined as neither resolution nor improvement of all signs and symptoms (total score equal, or <50%, or higher than baseline), assessed at Visit 3, or at ETTV/ETV; · the clinical efficacy, assessed as the sum of the differences of the scores at each time point and baseline for each sign and symptom, estimated as the area under the differences, up to Visit 1 (at 24h after the first drug administration), or up to ETTV/ETV; · the therapeutic cure, assessed as combined mycological and clinical cure at Visit 4 (TOC), or at ETTV/ETV; · the acceptability assessment at Visit 2, or at ETTV; · the recurrent episode of uncomplicated VVC, assessed at the Follow-up Visit; · the safety evaluation.;Timepoint(s) of evaluation of this end point: - the time to total symptoms relief will be evaluated up to Visit 4; - the clinical response will be evaluated up to Visit 1 or at ETTV/ETV; - the clinical efficacy, in terms of clinical cure, clinical improvement and clinical failure will be evaluated at Visit 3, or at ETTV/ETV; - the clinical efficacy, assessed as the sum of the differences of the scores at each time point and baseline for each sign and symptom estimated as the area under the dif | — |
Countries
Bulgaria, Hungary, Italy, Poland, Russian Federation
Contacts
Public ContactDr. Annalisa Bonelli
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Outcome results
None listed