If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Bacterial Vaginosis Cured In Three Days With New Cleocin Vaginal Ovule SAN DIEGO, CA -- Sept. 25, 1998 -- The first three-day ovule treatment for bacterial vaginosis (BV) in non-pregnant women was the focus of a study presented at the 38th interscience conference on Antimicrobial Agents and Chemotherapy (ICAAC). The preliminary data presented indicate that Pharmacia & Upjohn, Inc.’s Cleocin(R) Vaginal Ovules (clindamycin phosphate vaginal suppositories) cure BV in nearly half the time of current standard therapies. Cleocin Vaginal Ovules are small tablets that are inserted vaginally. Based on this data, an application will be submitted to the FDA to consider approval of Cleocin as a three-day ovule treatment. Cleocin Vaginal Ovules, a new formulation of clindamycin phosphate, provide a unique delivery system as compared to current therapy. The ovules offer women an alternate three-day treatment option while adding the ease and convenience of an ovule formulation. Cleocin Vaginal Cream was first marketed in the U.S. in 1992 as a seven-day treatment and was recently approved as the first three-day treatment for BV in non-pregnant women. Pseudomembranous colitis should be considered in patients who present with diarrhea subsequent to using Cleocin Vaginal Cream. Bacterial vaginosis is the most common type of vaginal infection in women of reproductive age and accounts for one-third of all vaginal infections. Experts estimate that BV is found in 10 percent to 64 percent of women visiting health clinics. Although BV is curable, if left untreated it can cause complications ranging from pelvic infection to miscarriage to increased susceptibility to sexually transmitted diseases including HIV, the virus that causes AIDS. In healthy women, certain bacteria live in the vagina and fight off other bacteria that can cause disease. BV is caused by the overgrowth of disease-causing bacteria when the normal environment of the vagina is disrupted. This may be caused by many things including douching, sexual relations or changes in the vaginal wall during the monthly cycle. The organisms which cause BV irritate the vaginal lining and lead to inflammation and discharge, which may allow pathogenic bacteria and viruses to enter, leading to increased susceptibility to serious, life-threatening illnesses. Symptoms of BV include a mild whitish discharge with a foul-smelling odour, especially after intercourse. However, nearly half of women with clinical signs of BV report no symptoms, underscoring the importance of BV screening during annual gynecological exams. Effective treatment of BV kills the pathogenic bacteria, allowing the normal, healthy bacteria to flourish. Three multicentre studies were performed in North America and Europe by Pharmacia & Upjohn to investigate the use of either clindamycin vaginal cream or a new clindamycin vaginal ovule for three-day treatment when compared to standard seven-day treatments with either metronidazole or clindamycin cream. In total, 1,642 non-pregnant women clinically diagnosed with BV and no other vaginal condition were treated with either clindamycin cream for three days (CVC3), clindamycin vaginal ovule for three days (CVO3), metronidazole tablets orally for seven days (MET7) or clindamycin vaginal cream for seven days (CVC7). All treatments were self-administered. Results of all three clinical studies showed that a three-day regimen of either clindamycin cream or ovule is as effective as a seven-day regimen of either metronidazole or clindamycin vaginal cream. In study number one, the cure rates were 90.1 percent for CVC3 and 92.8 percent for CVC7. In study number two, the cure rates were 86.7 percent for CVO3 and 85.7 percent for MET7. In study number three, the cure rates were 81.3 percent for CVO3 and 72.6 percent for CVC7. The infection was considered cured only when enough time had elapsed after therapy to assure the infection was resolved and not just mildly improved during therapy.
|
