The purpose is to study superior efficacy of combination of Natamycin and Lactulose (Natamycin 100 mg + Lactulose 300 mg vaginal suppositories) compared to Pimafucin (Natamycin 100 mg vaginal suppositories), or Lactulose 300 mg vaginal suppositories. The second objective of the study was to investigate the safety of the combination suppositories in the treatment of vulvovaginal candidiasis in non-pregnant adult females.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
218
1 suppository once daily at bedtime for 6 days
1 suppository once daily at bedtime for 6 days
1 suppository once daily at bedtime for 6 days
Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University
Moscow, Russia
Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2
The clinical response was considered as the absence of significant signs and symptoms of VVC (white or yellowish-white curd-like, thick, or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination \[dysuria\])
Time frame: 7 days
Proportion (%) of patients with the clinical response at Visit 3
The clinical response was considered as the absence of significant signs and symptoms of VVC (white or yellowish-white curd-like, thick, or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination \[dysuria\])
Time frame: 24 days
Proportion (%) of patients with microscopic recovery (absence of Candida spp. at Visits 2 and 3
The vaginal culture test for Candida spp. was used for the microscopic assessment
Time frame: 24 days
Proportion of patients with overall (clinical and microscopic) recovery at Visits 2 and 3
The vaginal culture test was used for the microscopic assessment
Time frame: 24 days
Patient's efficacy assessment by the 5-point scale at Visits 2, 3
The patient completed a questionnaire in the presence of the investigating physician as part of the efficacy assessment. The questionnaire contained closed-ended responses ranging from 1 point (no clinical symptoms) to 5 points (severe clinical symptoms)
Time frame: 24 days
Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3 compared to baseline (Visit 0)
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Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3
Time frame: 24 days
Incidence of adverse events
incidence of any adverse events, an incidence of serious adverse events (SAEs), an incidence of AEs and SAEs probably related (in the investigator's opinion) with the study drug at the study dose, and an incidence of AEs and SAEs that led to study drug discontinuation.
Time frame: 24 days