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

NCT06411314 | Completed Phase 3 DMC

• 1 other identifier: 12/21-AVVA RUS
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvovaginal Candidiasis, Genital

Keywords

vulvovaginal candidiasis; itching; Natamycin; Lactulose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion (%) of patients with the clinical response at Visit 3

  24 days

• Proportion (%) of patients with microscopic recovery (absence of Candida spp. at Visits 2 and 3

  24 days

• Proportion of patients with overall (clinical and microscopic) recovery at Visits 2 and 3

  24 days

• Patient's efficacy assessment by the 5-point scale at Visits 2, 3

  24 days

• Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3 compared to baseline (Visit 0)

  24 days

Study Arms (3)

Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories

EXPERIMENTAL

Combination Product: Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories

Lactulose 300 mg vaginal suppositories

ACTIVE COMPARATOR

Drug: Lactulose 300 mg vaginal suppositories

Pimafucin® (natamycin) 100 mg vaginal suppositories

ACTIVE COMPARATOR

Drug: Pimafucin® (natamycin) 100 mg vaginal suppositories

Interventions

Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories COMBINATION_PRODUCT

1 suppository once daily at bedtime for 6 days

Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories

Lactulose 300 mg vaginal suppositories DRUG

1 suppository once daily at bedtime for 6 days

Lactulose 300 mg vaginal suppositories

Pimafucin® (natamycin) 100 mg vaginal suppositories DRUG

1 suppository once daily at bedtime for 6 days

Pimafucin® (natamycin) 100 mg vaginal suppositories

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avva Rus, JSC: lead

Study Sites (1)

Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University

Moscow, Russia

Location

Related Publications (1)

• Volkova ON, Amel'chenko EV, Makeeva OV, Tolmachev SA, Lesovaya EA, Zacharia LC, Dikovskiy AV. Efficacy and safety of vaginal suppositories containing combination of Natamycin and Lactulose in treatment of vulvovaginal candidiasis: international, randomized, controlled, superiority clinical trial (combination of Natamycin and Lactulose for treatment of vulvovaginal candidiasis). BMC Womens Health. 2025 Feb 20;25(1):77. doi: 10.1186/s12905-025-03616-3.

  PMID: 39979898 DERIVED

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Pruritus

Interventions

Natamycin; Lactulose; Suppositories

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: December 29, 2022
• Primary Completion: July 26, 2023
• Study Completion: September 22, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

RU (1)