Approval Probability
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Adjusted LOA
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tetracycline/ amphotericin B · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| clindamycin/ketoconazole combination | EXPERIMENTAL | - |
| tetracycline hydrochloride/amphotericin B combination | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 100 mg clindamycin /800 mg ketoconazole vaginal ovule | DRUG | 1 vaginal ovule for 3 consecutive days |
| 100 mg tetracycline hydrochloride /50 mg amphotericin B cream | DRUG | 1 applicator (4 g) full of cream intravaginally for 7 to 10 days |
Inclusion Criteria: * Diagnosis of vaginal candidiasis * No Trichomonas vaginalis or any other protozoa * No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections Exclusion Criteria: * Known sensitivity to the formula components * Pregnant or nursing...
Tetracycline/amphotericin B is an investigational combination cream being studied for the treatment of bacterial vaginosis. It combines two anti-infective small molecules in a single topical formulation. The only recorded clinical trial also enrolled patients with vulvovaginal candidiasis alongside bacterial vaginosis.
Tetracycline/amphotericin B is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the Phase 3 study that evaluated the combination cream in bacterial vaginosis and vulvovaginal candidiasis.
Tetracycline/amphotericin B has been studied in a Phase 3 clinical trial, which is now completed. It is an investigational product and is not described as approved for any indication. No active trials of this combination are currently listed.
Tetracycline/amphotericin B was evaluated in one completed Phase 3 trial, NCT01293643, titled a study comparing ketoconazole and clindamycin with the tetracycline/amphotericin B combination cream for bacterial vaginosis and vaginal candidiasis. The randomized, active-controlled study enrolled 99 female participants aged 18 years and older.