Health Trials

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

ConditionsCandidal Vulvovaginitis (ICD-10 Code: B37.3)Vulvovaginal Candidiasis (VVC)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorAVVA Pharmaceuticals Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy or breastfeeding.

Diagnosed bacterial vaginosis.

Chronic inflammatory or atrophic diseases of the female genital organs.

History of malignant neoplasms.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clotrimazole+Lactulose.

    Drug

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

  • Canesten (Clotrimazole)

    Drug

    Vaginal tablets containing clotrimazole (100 mg)

  • Lactulose

    Drug

    Vaginal suppositories containing lactulose (300 mg)

Treatment groups

264 Participants
are divided into 3 treatment groups
Group A: Clotrimazole+LactuloseExperimental treatment 1 intervention
Group B: Canesten (Clotrimazole)Active comparator 1 intervention
Group C: LactulosePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion (%) of patients with clinical and microbiological response (recovery)

Time frame
Day 25 (Visit 4)

Secondary outcomes

1

Proportion (%) of patients with clinical response (recovery)

Time frame
by Visits 2 (Day 8) and 3 (Day 15)
2

Proportion (%) of patients with microbiological recovery

Time frame
by Visits 2 (Day 8) and 3 (Day 15)
3

Assessment of the severity of subjective and objective signs and symptoms on a 4-point scale

Time frame
by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
4

Patient evaluation of therapy efficacy using a 5-point scale

Time frame
at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AVVA Pharmaceuticals Ltd.

Lead sponsor

Source ClinicalTrials.gov
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