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

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.

Timeline

Start

2022-12-29

Primary completion

2023-07-26

Completion

2023-09-22

Publications

• 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.

Drugs

Indications