NCT06835361 Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
| NCT ID | NCT06835361 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | AVVA Pharmaceuticals Ltd. |
| Condition | Candidal Vulvovaginitis (ICD-10 Code: B37.3) |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2024-02-29 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 264 participants in total. It began in 2024-02-29 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06835361 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Candidal Vulvovaginitis (ICD-10 Code: B37.3). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06835361 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06835361 currently recruiting?
Yes, NCT06835361 is actively recruiting participants. Contact the research team at tolmachev@rnd.avvapharma.com for enrollment information.
Where is the NCT06835361 trial being conducted?
This trial is being conducted at Minsk, Belarus, Minsk, Belarus, Minsk, Belarus, Minsk, Belarus and 3 additional locations.
Who is sponsoring the NCT06835361 clinical trial?
NCT06835361 is sponsored by AVVA Pharmaceuticals Ltd.. The trial plans to enroll 264 participants.