Vulvovaginal Candidiasis, Genital
Conditions
Keywords
vulvovaginal candidiasis, itching, Natamycin, Lactulose
Brief summary
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.
Interventions
COMBINATION_PRODUCTNatamycin + Lactulose 100 mg + 300 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
DRUGLactulose 300 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
DRUGPimafucin® (natamycin) 100 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
Sponsors
Avva Rus, JSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* two or more of the following signs and symptoms of vulvovaginal candidiasis: 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); * yeast cells in the vaginal swab specimen; * vaginal pH ≤ 4.5.
Exclusion criteria
* a clinical and laboratory diagnosis of bacterial vaginosis; vulvovaginitis caused by specific pathogens such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae; chronic inflammatory, atrophic, or oncologic diseases of the female genital tract; previous surgery on external or internal genitalia within 6 months; childbirth and abortion within 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2 | 7 days | 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 \[dysuria\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion (%) of patients with microscopic recovery (absence of Candida spp. at Visits 2 and 3 | 24 days | The vaginal culture test for Candida spp. was used for the microscopic assessment |
| Proportion of patients with overall (clinical and microscopic) recovery at Visits 2 and 3 | 24 days | The vaginal culture test was used for the microscopic assessment |
| Proportion (%) of patients with the clinical response at Visit 3 | 24 days | 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 \[dysuria\]) |
| Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3 compared to baseline (Visit 0) | 24 days | Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3 |
| Incidence of adverse events | 24 days | 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. |
| Patient's efficacy assessment by the 5-point scale at Visits 2, 3 | 24 days | 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) |
Countries
Russia
Outcome results
None listed