Currently Enrolling Trials
Cleocin (clindamycin phosphate) is an antibiotic.
Cleocin is specifically indicated for the treatment of bacterial vaginosis.
Cleocin is supplied as a vaginal cream. The recommended dose is one applicatorful of clindamycin phosphate vaginal cream 2%, (5 grams containing approximately 100 mg of clindamycin phosphate) intravaginally, preferably at bedtime, for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients.
Mechanism of Action
Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is predominantly bacteriostatic. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts it to active clindamycin.
Adverse effects associated with the use of Cleocin may include, but are not limited to, the following:
- unpleasant or metallic taste in the mouth
- joint pain
- pain when swallowing
- white patches in the mouth
- thick, white vaginal discharge
- burning, itching, and swelling of the vagina
Clinical Trial Results
The FDA approval of Cleocin was based on two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing Cleocin Vaginal Cream 2% for 3 or 7 days. The clinical cure rates, determined at 1 month post-therapy, ranged from 72% to 81% for the 3-day treatment and 84% to 86% for the 7-day treatment.
In a clinical study involving 249 evaluable pregnant patients in the second and third trimester treated for 7 days, the clinical cure rate, determined at 1 month post-therapy, was 60% (77/129) in the clindamycin arm and 9% (11/120) for the vehicle arm. The determination of clinical cure was based on the absence of a "fishy" amine odor when the vaginal discharge was mixed with a 10% KOH solution and the absence of clue cells on microscopic examination.