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

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

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

Treatments tested in this trial

  • Clotrimazole+Lactulose.
  • Canesten (Clotrimazole)
  • Lactulose

Treatment groups

264 Participants
are divided into 3 treatment groups

Sponsors and collaborators