Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis

AVVA Pharmaceuticals

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Candidal Vulvovaginitis (ICD-10 Code: B37.3); Vulvovaginal Candidiasis (VVC)

Treatments: Drug: Lactulose; Drug: Canesten (Clotrimazole); Drug: Clotrimazole+Lactulose.

Study type: Interventional

Funder types: Industry

Identifiers

NCT06835361

Clotrimazole+Lactulose-II/III

Details and patient eligibility

About

This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.

Full description

The study was conducted using an adaptive design to evaluate the impact of lactulose on the course of fungal infections. The primary endpoint was the proportion of patients achieving clinical and microbiological recovery on Day 25 (Visit 4). Secondary endpoints included assessment of symptom severity, changes in Lactobacillus content, and patient satisfaction with therapy. Participants were randomized into three groups: Clotrimazole+Lactulose, Canesten, and Lactulose.

Enrollment: 264 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18 to 60 years.
• Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.
• Negative pregnancy test at screening.
• Agreement to use reliable contraception throughout the study and for 30 days after its completion.
• Signed informed consent.

Exclusion criteria

• Pregnancy or breastfeeding.
• Diagnosed bacterial vaginosis.
• Chronic inflammatory or atrophic diseases of the female genital organs.
• History of malignant neoplasms.
• Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 3 patient groups, including a placebo group

Clotrimazole+Lactulose

Experimental group

Description:

Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)

Treatment:

Drug: Clotrimazole+Lactulose.

Canesten (Clotrimazole)

Active Comparator group

Description:

Vaginal tablets containing clotrimazole (100 mg)

Treatment:

Drug: Canesten (Clotrimazole)

Lactulose

Placebo Comparator group

Description:

Vaginal suppositories containing lactulose (300 mg)

Treatment:

Drug: Lactulose