Comparing Clotrimazole with and without Lactulose for treating vaginal yeast infections in women
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
This study is testing if adding Lactulose to Clotrimazole can help women with vaginal yeast infections feel better and recover faster compared to using Clotrimazole alone.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | AVVA Pharmaceuticals Ltd. Industry-sponsored |
| Locations | 7 sites (Minsk, Minsk City and 6 other locations) |
| Trial ID | NCT06835361 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a combination treatment of Clotrimazole and Lactulose compared to Clotrimazole alone in adult women diagnosed with candidal vulvovaginitis. The research employs an adaptive design to assess the impact of Lactulose on fungal infections, focusing on clinical and microbiological recovery by Day 25. Participants are randomized into three groups: those receiving the combination treatment, those receiving Clotrimazole alone, and those receiving Lactulose. Secondary endpoints include symptom severity, changes in Lactobacillus levels, and patient satisfaction.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 60 with a confirmed diagnosis of candidal vulvovaginitis.
Not a fit: Patients who are pregnant, breastfeeding, or have other specific gynecological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women suffering from candidal vulvovaginitis.
How similar studies have performed: Other studies have shown promising results with combination therapies for fungal infections, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minsk, Minsk City and 6 other locations
- Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk" — Minsk, Minsk City, Belarus (Recruiting)
- Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk" — Minsk, Belarus (Recruiting)
- Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk" — Minsk, Belarus (Recruiting)
- Healthcare Institution "4th City Polyclinic" of Minsk — Minsk, Belarus (Recruiting)
- Healthcare Institution "5th City Clinical Polyclinic" of Minsk — Minsk, Belarus (Recruiting)
- State Institution "Republican Center of Medical Rehabilitation and Balneotherapy" — Minsk, Belarus (Recruiting)
- SBI RR "Regional Clinical Skin and Venereal Dispensary" — Ryazan, Ryazan Oblast, Russia (Recruiting)
Study contacts
- Study coordinator: Sergey Tolmachev
- Email: tolmachev@rnd.avvapharma.com
- Phone: +7 495 2690016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.