Clinical trial NCT06835361: Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
Official title: International Open-label Randomized Comparative Clinical Study of Efficacy and Safety of Clotrimazole+Lactulose, Vaginal Suppositories (AVVA RUS JSC, Russia) Vs. a Clotrimazole Monocomponent Product in Adult Female Patients with Candidal Vaginitis/vulvovaginitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Candidal Vulvovaginitis (ICD-10 Code: B37.3)
Vulvovaginal Candidiasis (VVC)
Keywords: Clotrimazole+Lactulose
Candidal Vulvovaginitis
Vulvovaginal Candidiasis
Clotrimazole
Lactulose
Antifungal Therapy
Prebiotic
Vaginal Suppositories
Canesten
Microbiological Recovery
Women&#39;s Health
Vaginal Microbiota
Lead sponsor: AVVA Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion (%) of patients with clinical and microbiological response (recovery)
timeFrame: Day 25 (Visit 4)
Secondary outcomes:
measure: Proportion (%) of patients with clinical response (recovery)
timeFrame: by Visits 2 (Day 8) and 3 (Day 15)
measure: Proportion (%) of patients with microbiological recovery
timeFrame: by Visits 2 (Day 8) and 3 (Day 15)
measure: Assessment of the severity of subjective and objective signs and symptoms on a 4-point scale
timeFrame: by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
measure: Patient evaluation of therapy efficacy using a 5-point scale
timeFrame: at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
measure: Change in Lactobacillus content as determined by molecular biological examination of vaginal secretions (real-time PCR) compared to baseline
timeFrame: by Visits 3 (Day 15) and 4 (Day 25)
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"
city: Minsk
country: Belarus
facility: Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"
city: Minsk
country: Belarus
facility: Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"
city: Minsk
country: Belarus
facility: Healthcare Institution "4th City Polyclinic" of Minsk
city: Minsk
country: Belarus
facility: Healthcare Institution "5th City Clinical Polyclinic" of Minsk
city: Minsk
country: Belarus
facility: State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"
city: Ryazan
country: Russian Federation
facility: SBI RR "Regional Clinical Skin and Venereal Dispensary"
state: Ryazanskaya oblast
Study officials:
References: