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

Recruiting now · Phase 2/Phase 3

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

In brief

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.

Key facts

Study ID

NCT06835361

Run by

AVVA Pharmaceuticals Ltd.

People needed

264

Starts

2024-02-29

Expected to finish

2025-11-30

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk" — Minsk, Minsk City, Belarus (enrolling)
• Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk" — Minsk, Belarus (enrolling)
• Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk" — Minsk, Belarus (enrolling)
• Healthcare Institution "4th City Polyclinic" of Minsk — Minsk, Belarus (enrolling)
• Healthcare Institution "5th City Clinical Polyclinic" of Minsk — Minsk, Belarus (enrolling)
• State Institution "Republican Center of Medical Rehabilitation and Balneotherapy" — Minsk, Belarus (enrolling)
• SBI RR "Regional Clinical Skin and Venereal Dispensary" — Ryazan, Ryazan Oblast, Russia (enrolling)

Full record on ClinicalTrials.gov

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