A Phase 2/3 interventional study of Clotrimazole+Lactulose. and Canesten (Clotrimazole) in Candidal Vulvovaginitis (ICD-10 Code: B37.3) and Vulvovaginal Candidiasis (VVC), sponsored by AVVA Pharmaceuticals Ltd.. Recruiting at 7 sites in 2 countries. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by AVVA Pharmaceuticals Ltd. · Phase 2/3, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.
This study's planned enrollment of 264 is above the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.
Browse Candidiasis, Vulvovaginal studies →AVVA Pharmaceuticals Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Drug: Clotrimazole+Lactulose.
Vaginal tablets containing clotrimazole (100 mg)
Drug: Canesten (Clotrimazole)
Vaginal suppositories containing lactulose (300 mg)
Drug: Lactulose
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Vaginal tablets containing clotrimazole (100 mg)
Vaginal suppositories containing lactulose (300 mg)
Proportion (%) of patients with clinical and microbiological response (recovery)
Time frame: Day 25 (Visit 4)
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)
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Sep 2025, 19 months after the start.
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AVVA Pharmaceuticals Ltd.