Comparing Clotrimazole with and without Lactulose for treating vaginal yeast infections in women
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
Run by AVVA Pharmaceuticals Ltd. · NCT06835361 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 264 (estimated) |
| Sponsor | AVVA Pharmaceuticals Ltd. Industry-sponsored |
| Locations | 7 sites (Minsk, Minsk City and 6 other locations) |
| Status | Recruiting |
| Started | February 29, 2024 |
| Main results expected | September 30, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | February 19, 2025 |
| Trial ID | NCT06835361 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 to 60 with a confirmed diagnosis of candidal vulvovaginitis.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have other specific gynecological conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with combination therapies for fungal infections, suggesting potential success for this approach.
Who can join: the full rules
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 it's running
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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
Show 1 more location
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Bioithas WOMAN as an added treatment for vulvovaginal candidiasis
We’re testing whether adding Bioithas WOMAN probiotic to standard antifungal treatment helps women with vulvovaginal candidiasis.
-
Vaginal cooling device for treating vulvovaginal yeast infections
This tests a vaginal cooling device to see if it helps women aged 22–49 with vulvovaginal yeast infections feel better and clear the infection.
-
Using a multi-strain probiotic to reduce recurrent vulvovaginal candidiasis
This study is testing if a special probiotic can help women aged 18-50 with frequent yeast infections feel better and have fewer episodes.
-
Evaluating the safety of ibrexafungerp in pregnant women and their infants
This study is testing whether ibrexafungerp is safe for pregnant women and their babies by looking at their health during and after pregnancy.
-
Effects of a lactic acid gel on vaginal health
This study is testing if the contraceptive Phexxi can improve vaginal health by increasing good bacteria and reducing discomfort for women.
-
Biweekly long-term Ocfidiofungin for recurrent vulvovaginal candidiasis in women
This study tests whether OCF001 intravaginal gel can safely and effectively reduce symptoms and recurrence in women with vulvovaginal candidiasis compared with a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.