This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.
The study was conducted using an adaptive design to evaluate the impact of lactulose on the course of fungal infections. The primary endpoint was the proportion of patients achieving clinical and microbiological recovery on Day 25 (Visit 4). Secondary endpoints included assessment of symptom severity, changes in Lactobacillus content, and patient satisfaction with therapy. Participants were randomized into three groups: Clotrimazole+Lactulose, Canesten, and Lactulose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
264
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Vaginal tablets containing clotrimazole (100 mg)
Vaginal suppositories containing lactulose (300 mg)
Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"
Minsk, Minsk City, Belarus
RECRUITINGHealthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"
Minsk, Belarus
RECRUITINGHealthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"
Minsk, Belarus
RECRUITINGHealthcare Institution "4th City Polyclinic" of Minsk
Minsk, Belarus
RECRUITINGHealthcare Institution "5th City Clinical Polyclinic" of Minsk
Minsk, Belarus
RECRUITINGState Institution "Republican Center of Medical Rehabilitation and Balneotherapy"
Minsk, Belarus
RECRUITINGSBI RR "Regional Clinical Skin and Venereal Dispensary"
Ryazan, Ryazan Oblast, Russia
RECRUITINGProportion (%) of patients with clinical and microbiological response (recovery)
Time frame: Day 25 (Visit 4)
Proportion (%) of patients with clinical response (recovery)
Time frame: by Visits 2 (Day 8) and 3 (Day 15)
Proportion (%) of patients with microbiological recovery
Time frame: by Visits 2 (Day 8) and 3 (Day 15)
Assessment of the severity of subjective and objective signs and symptoms on a 4-point scale
Time frame: by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
Patient evaluation of therapy efficacy using a 5-point scale
Time frame: at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
Change in Lactobacillus content as determined by molecular biological examination of vaginal secretions (real-time PCR) compared to baseline
Time frame: by Visits 3 (Day 15) and 4 (Day 25)
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