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NCT Number: NCT06411314

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories

Combination Product

1 suppository once daily at bedtime for 6 days

Lactulose 300 mg vaginal suppositories

Drug

1 suppository once daily at bedtime for 6 days

Pimafucin® (natamycin) 100 mg vaginal suppositories

Drug

1 suppository once daily at bedtime for 6 days

Primary outcomes

  1. Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2

    Time frame: 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 outcomes

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

    Time frame: 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])

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

    Time frame: 24 days

    The vaginal culture test for Candida spp. was used for the microscopic assessment

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

    Time frame: 24 days

    The vaginal culture test was used for the microscopic assessment

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

    Time frame: 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)

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

    Time frame: 24 days

    Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3

  6. Incidence of adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Avva Rus, JSC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 13, 2024
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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