Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clotrimazole, vaginal ovule · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Clotrimazole tablet (Canesten, BAY-B5097) | ACTIVE_COMPARATOR | Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0). |
| Clotrimazole ovule (Canesten, BAY-B5097) | EXPERIMENTAL | Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0). |
| Name | Type | Description |
|---|---|---|
| Clotrimazole, vaginal ovule | DRUG | Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0). |
| Clotrimazole, vaginal tablet | DRUG | Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0). |
Inclusion Criteria: * Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years. * Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation). * Subjects must be cooperative, able...
Clotrimazole vaginal ovule is used for the treatment of vulvovaginal candidiasis, a fungal infection of the vagina. It is a small molecule antifungal drug administered as a vaginal ovule. The drug is being developed by Bayer AG for this infectious disease indication.
Clotrimazole vaginal ovule is developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical development of this antifungal treatment for vulvovaginal candidiasis.
Clotrimazole vaginal ovule is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with no active trials currently ongoing.
Clotrimazole vaginal ovule has one completed Phase 3 clinical trial, identified as NCT00755053. This trial, titled 'Comparative Efficacy of Ovule vs Tablet', enrolled 466 female participants aged 14 years and older in Germany and Russia. The study compared the ovule formulation against a tablet formulation.
Clotrimazole vaginal ovule is a specific dosage form of the antifungal drug clotrimazole. While clotrimazole is available in various formulations, the vaginal ovule is a solid dosage form inserted into the vagina. The clinical trial NCT00755053 compares this ovule formulation to a tablet formulation.
Clotrimazole vaginal ovule works by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes. This disruption leads to increased membrane permeability and leakage of cellular contents, ultimately causing fungal cell death. This mechanism makes it effective against Candida species causing vulvovaginal candidiasis.