C-VAD™ For Bacterial Vaginosis
Bacterial vaginosis (BV), previously known as non-specific vaginosis or Gardnerella vaginitis is the most common cause of abnormal vaginal discharge in women of childbearing age. In the USA as many as 16% of pregnant women have BV. BV is an imbalance of vaginal flora caused by a reduction of the normal Lactobacilli species, and a heavy overgrowth of mixed anaerobic flora including Gardnerella vaginalis, Mycoplasma hominis, Mobiluncus spp. and Bacteroides spp.

The cause of the change in the vaginal flora is unknown. BV is not thought to be sexually transmitted but may be associated with sexual activity BV can arise and remit spontaneously in sexually active and non-sexually active women, and treatment of male partners does not reduce recurrence rates. Its onset has been associated with a change of sexual partner and vaginal douching.

Risk factors also include use of an intra-uterine contraceptive device, early age of first intercourse and a higher number of lifetime sexual partners. BV is often asymptomatic but may result in a vaginal discharge, which can be grey in colour with a characteristic 'fishy' odour. It is not associated with inflammation of the vaginal mucosa and rarely causes vulval itch.

BV is associated with an increase in the risk of developing several pathological disorders. During pregnancy, bacterial vaginosis is associated with amniotic fluid infection, clinical chorioamnionitis, post-partum haemorrhage, and premature rupture of membranes, low birth weight, and pre-term labour. Multiple studies have identified BV as a risk factor for pre-term labour (PTL). It is not clear whether BV is the cause of PTL or is only an association.

There are both local and systemic approaches to treat BV, and a number of preparations are available. The active ingredient in these preparations is either clindamycin phosphate or metronidazole.

Cleocin® or Dalacin® is clindamycin phosphate cream administered intravaginally for seven consecutive days. Cleocin® Ovules are an intravaginal formulation that is used for three consecutive days. Clindesse™ cream is a single dose vaginal treatment containing Clindamycin phosphate. Metronidazole products licensed for this indication are Metrogel® vaginal gel and Flagyl® oral metronidazole in various tablet strengths.

Antibiotic-associated colitis is a known side effect of oral clindamycin treatment but is considered less of an issue with vaginal administration. Clindamycin has a broader antimicrobial spectrum than metronidazole and is also active against Mobiluncus and Mycoplasmas.

The Controlled Therapeutics C-Vad™ vaginal insert has been developed to treat bacterial vaginosis in a convenient patient friendly vaginal insert. This avoids leakage of the drug and staining of underclothes associated with creams and ovules. CT have carried out a volunteer study to assess the release of drug from the polymer inserts. The data obtained is now being applied to the development of a product which will be tested in patients with BV in 2005.

Controlled Therapeutics (Scotland) Ltd. • 1 Redwood Place • Peel Park Campus • East Kilbride • G74 5PB • Tel (+44) 1355 239166 • Fax (+44) 1355 263661