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.
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