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

AVVA Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Vulvovaginal Candidiasis, Genital

Treatments: Combination Product: Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories; Drug: Pimafucin® (natamycin) 100 mg vaginal suppositories; Drug: Lactulose 300 mg vaginal suppositories

Study type: Interventional

Funder types: Industry

Identifiers

NCT06411314

12/21-AVVA RUS

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 3 patient groups

Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories

Experimental group

Treatment:

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

Lactulose 300 mg vaginal suppositories

Active Comparator group

Treatment:

Drug: Lactulose 300 mg vaginal suppositories

Pimafucin® (natamycin) 100 mg vaginal suppositories

Active Comparator group

Treatment:

Drug: Pimafucin® (natamycin) 100 mg vaginal suppositories