Candidal Vulvovaginitis (ICD-10 Code: B37.3)Phase 2/3NCT06835361
Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
A Phase 2/3 study testing Clotrimazole+Lactulose., Canesten (Clotrimazole) and Lactulose in people with Candidal Vulvovaginitis (ICD-10 Code: B37.3) and Vulvovaginal Candidiasis (VVC), run by AVVA Pharmaceuticals Ltd. at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Candidal Vulvovaginitis (ICD-10 Code: B37.3), Vulvovaginal Candidiasis (VVC)
- What is being tested?
- Clotrimazole+Lactulose., Canesten (Clotrimazole) and Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 29 Feb 2024to 30 Nov 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Belarus6 sites, 6 recruiting
- Recruiting
Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"
Minsk, Minsk City, 220004
Alina V Krakasevich, info@1crp.by
- Recruiting
Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"
Minsk
Elena V Golovko, +375 17 200 18 96, info@14crp.by
- Recruiting
Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"
Minsk
Elena E Yarosh, +375 17 256 56 42, lpu2crp@gmail.com
- Recruiting
Healthcare Institution "4th City Polyclinic" of Minsk
Minsk
Elena A Malyavskaya, +375 17 374-67-69, info@4gp.by
- Recruiting
Healthcare Institution "5th City Clinical Polyclinic" of Minsk
Minsk
Veronika D Babkova, +375 17 278 10 70, info@5gp.by
- Recruiting
State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"
Minsk
Larisa I Ershova, +375 17 358 90 92, center@makaenka17med.by
Russia1 site, 1 recruiting
- Recruiting
SBI RR "Regional Clinical Skin and Venereal Dispensary"
Ryazan, Ryazan Oblast
Dmitry Sonin, +7 (4912) 27-50-82, okkvd@ryazan.gov.ru
About this study
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
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.
Read the detailed description
The study was conducted using an adaptive design to evaluate the impact of lactulose on the course of fungal infections. The primary endpoint was the proportion of patients achieving clinical and microbiological recovery on Day 25 (Visit 4). Secondary endpoints included assessment of symptom severity, changes in Lactobacillus content, and patient satisfaction with therapy. Participants were randomized into three groups: Clotrimazole+Lactulose, Canesten, and Lactulose.
- Being tested
- Clotrimazole+Lactulose., Canesten (Clotrimazole), Lactulose
- Keywords
- Clotrimazole+Lactulose, Candidal Vulvovaginitis, Vulvovaginal Candidiasis, Clotrimazole, Lactulose, Antifungal Therapy, Prebiotic, Vaginal Suppositories, Canesten, Microbiological Recovery, Women's Health, Vaginal Microbiota
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clotrimazole+Lactulose.Drug
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Canesten (Clotrimazole)Drug
Vaginal tablets containing clotrimazole (100 mg)
LactuloseDrug
Vaginal suppositories containing lactulose (300 mg)
| Study group | Role | What they receive |
|---|---|---|
| Clotrimazole+Lactulose | Experimental | Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg) Receives: Drug: Clotrimazole+Lactulose. |
| Canesten (Clotrimazole) | Active comparator | Vaginal tablets containing clotrimazole (100 mg) Receives: Drug: Canesten (Clotrimazole) |
| Lactulose | Placebo comparator | Vaginal suppositories containing lactulose (300 mg) Receives: Drug: Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of patients with clinical and microbiological response (recovery)
Measured: Day 25 (Visit 4)
Secondary outcomes (5)
Proportion (%) of patients with clinical response (recovery)
Measured: by Visits 2 (Day 8) and 3 (Day 15)
Proportion (%) of patients with microbiological recovery
Measured: by Visits 2 (Day 8) and 3 (Day 15)
Assessment of the severity of subjective and objective signs and symptoms on a 4-point scale
Measured: by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
Patient evaluation of therapy efficacy using a 5-point scale
Measured: at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
Change in Lactobacillus content as determined by molecular biological examination of vaginal secretions (real-time PCR) compared to baseline
Measured: by Visits 3 (Day 15) and 4 (Day 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start29 Feb 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidal Vulvovaginitis (ICD-10 Code: B37.3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AVVA Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835361
- Sponsor's protocol ID
- Clotrimazole+Lactulose-II/III
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06835361
- Acronym / sponsor ID
- Clotrimazole+Lactulose-II/III
- Keywords
- Clotrimazole+Lactulose, Candidal Vulvovaginitis, Vulvovaginal Candidiasis, Clotrimazole, Lactulose, Antifungal Therapy, Prebiotic, Vaginal Suppositories
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- AVVA Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was conducted using an adaptive design to evaluate the impact of lactulose on the course of fungal infections. The primary endpoint was the proportion of patients achieving clinical and microbiological recovery on Day 25 (Visit 4). Secondary endpoints included assessment of symptom severity, changes in Lactobacillus content, and patient satisfaction with therapy. Participants were randomized into three groups: Clotrimazole+Lactulose, Canesten, and Lactulose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clotrimazole+Lactulose | Experimental | Drug: Clotrimazole+Lactulose.Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg) |
| Canesten (Clotrimazole) | Active comparator | Drug: Canesten (Clotrimazole)Vaginal tablets containing clotrimazole (100 mg) |
| Lactulose | Placebo comparator | Drug: LactuloseVaginal suppositories containing lactulose (300 mg) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clotrimazole+Lactulose.Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg) | Drug | Clotrimazole+Lactulose |
| Canesten (Clotrimazole)Vaginal tablets containing clotrimazole (100 mg) | Drug | Canesten (Clotrimazole) |
| LactuloseVaginal suppositories containing lactulose (300 mg) | Drug | Lactulose |
Primary outcome
Proportion (%) of patients with clinical and microbiological response (recovery)
Time frame: Day 25 (Visit 4)
5 secondary outcomes
Proportion (%) of patients with clinical response (recovery)
Time frame: by Visits 2 (Day 8) and 3 (Day 15)
Proportion (%) of patients with microbiological recovery
Time frame: by Visits 2 (Day 8) and 3 (Day 15)
Assessment of the severity of subjective and objective signs and symptoms on a 4-point scale
Time frame: by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
Patient evaluation of therapy efficacy using a 5-point scale
Time frame: at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
Change in Lactobacillus content as determined by molecular biological examination of vaginal secretions (real-time PCR) compared to baseline
Time frame: by Visits 3 (Day 15) and 4 (Day 25)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clotrimazole+Lactulose., Canesten (Clotrimazole) and Lactulose in people with Candidal Vulvovaginitis (ICD-10 Code: B37.3) and Vulvovaginal Candidiasis (VVC), run by AVVA Pharmaceuticals Ltd. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belarus, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergey Tolmachev (+7 495 2690016, tolmachev@rnd.avvapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (%) of patients with clinical and microbiological response (recovery) (time frame: Day 25 (Visit 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.