Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.
This was a national, randomized, 3-arms, phase III study conducted in 16 centers in Türkiye. It was aimed to evaluate the efficacy and safety of different fixed dose vaginal ovule formulations of fenticonazole + tinidazole + lidocaine (Formulation A and Formulation B) in the treatment of bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis and mixed infections with comparison to Gynomax® XL vaginal ovule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
577
EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)
Ege University Family Planning and Infertility Application and Research Center
Izmir, Turkey (Türkiye)
Percentage of patients who had complete response to treatment according to clinical findings
Efficacy
Time frame: 13 days (+/- 5 days) after treatment
Percentage of patients who had partial response to treatment according to clinical findings
Efficacy
Time frame: 13 days (+/- 5 days) after treatment
Percentage of patients who recovered according to microbiological findings
Efficacy
Time frame: 13 days (+/- 5 days) after treatment
Frequency and percentage of patients with SAEs/AEs in each arm
Safety
Time frame: 13 days (+/- 5 days)
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