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

Last updated: May 8, 2024
Sponsor: Avva Rus, JSC
Overall Status: Completed

Phase

3

Condition

Fungal Infections

Vaginitis

Yeast Infections

Treatment

Pimafucin® (natamycin) 100 mg vaginal suppositories

Lactulose 300 mg vaginal suppositories

Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories

Clinical Study ID

NCT06411314
12/21-AVVA RUS
  • Ages 18-60
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • two or more of the following signs and symptoms of vulvovaginal candidiasis: whiteor 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

Exclusion Criteria:

  • a clinical and laboratory diagnosis of bacterial vaginosis; vulvovaginitis caused byspecific pathogens such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseriagonorrhoeae; chronic inflammatory, atrophic, or oncologic diseases of the femalegenital tract; previous surgery on external or internal genitalia within 6 months;childbirth and abortion within 6 months.

Study Design

Total Participants: 218
Treatment Group(s): 3
Primary Treatment: Pimafucin® (natamycin) 100 mg vaginal suppositories
Phase: 3
Study Start date:
December 29, 2022
Estimated Completion Date:
September 22, 2023

Connect with a study center

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

    Moscow,
    Russian Federation

    Site Not Available

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