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clindamycin phosphate vaginal cream 2%
Clindamycin phosphate is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby killing or inhibiting the growth of anaerobic bacteria and some gram-positive organisms responsible for bacterial vaginosis.
Clindamycin phosphate is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby killing or inhibiting the growth of anaerobic bacteria and some gram-positive organisms responsible for bacterial vaginosis. Used for Bacterial vaginosis in non-pregnant women, Bacterial vaginosis in pregnant women (second and third trimester).
At a glance
| Generic name | clindamycin phosphate vaginal cream 2% |
|---|---|
| Sponsor | Actavis Inc. |
| Drug class | Lincosamide antibiotic |
| Target | Bacterial 50S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Gynecology |
| Phase | Phase 3 |
Mechanism of action
When applied as a vaginal cream, clindamycin phosphate is converted to its active form and penetrates vaginal tissues to suppress the growth of anaerobic bacteria that cause bacterial vaginosis. By disrupting bacterial protein synthesis, it restores the normal vaginal flora balance. The 2% formulation delivers therapeutic concentrations directly to the vaginal epithelium with minimal systemic absorption.
Approved indications
- Bacterial vaginosis in non-pregnant women
- Bacterial vaginosis in pregnant women (second and third trimester)
Common side effects
- Vulvovaginal irritation or itching
- Vaginal discharge or odor changes
- Vulvovaginal candidiasis (secondary yeast infection)
- Abdominal pain or cramping
Key clinical trials
- Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole (NA)
- The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation (NA)
- A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women (PHASE3)
- Treatment of Bacterial Vaginosis Combined With Human Lactobacilli (PHASE4)
- Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
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