Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis

Phase 3

Completed

• Conditions: Vulvovaginal Candidiasis, Genital
• Interventions: Combination Product: Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories; Drug: Pimafucin® (natamycin) 100 mg vaginal suppositories; Drug: Lactulose 300 mg vaginal suppositories

• Registration Number: NCT06411314
• Lead Sponsor: Avva Rus, JSC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-29
• Primary Completion: 2023-07-26
• Study Completion: 2023-09-22
• Status Verified: 2024-05
• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 218

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories	Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories	-
Pimafucin® (natamycin) 100 mg vaginal suppositories	Pimafucin® (natamycin) 100 mg vaginal suppositories	-
Lactulose 300 mg vaginal suppositories	Lactulose 300 mg vaginal suppositories	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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)
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.

Trial Locations

Locations (1)

Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University; 🇷🇺 Moscow, Russian Federation