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

Vulvovaginal Candidiasis, Genital Clinical Trial

Official title:

Efficacy and Safety of Vaginal Suppositories Containing Combination of Natamycin and Lactulose in Treatment of Vulvovaginal Candidiasis: International, Randomized, Controlled, Superiority Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06411314
• Other study ID #: 12/21-AVVA RUS
• Status: Completed
• Phase: Phase 3
• Start date: December 29, 2022
• Est. completion date: September 22, 2023

Study information

• Verified date: May 2024
• Source: Avva Rus, JSC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 22, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis, Genital

Intervention

Combination Product:
• Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days

Drug:
• Lactulose 300 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days
• Pimafucin® (natamycin) 100 mg vaginal suppositories
1 suppository once daily at bedtime for 6 days

Locations

Country	Name	City	State
Russian Federation	Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Avva Rus, JSC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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])	7 days
Secondary	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])	24 days
Secondary	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	24 days
Secondary	Proportion of patients with overall (clinical and microscopic) recovery at Visits 2 and 3	The vaginal culture test was used for the microscopic assessment	24 days
Secondary	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)	24 days
Secondary	Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3 compared to baseline (Visit 0)	Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3	24 days
Secondary	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.	24 days