Efficacy and tolerability of a new chlorhexidine-based vaginal gel in vaginal infections.
OBJECTIVE
We evaluated the efficacy and tolerability of a new chlorhexidine-based bioadhesive vaginal gel (Clomirex) in women with vaginal infections.


METHODS
A total of 90 nonpregnant women with vaginal infections of both bacterial (bacterial vaginosis: BV) or fungal (vaginal candidiasis VC) origin, were enrolled in the study: a randomised, controlled, 4-week, multicentre trial. Patients were randomly treated with either chlorhexidine 0.5% vaginal gel (CHX-VG), 2.5 g or with metronidazole vaginal tablets 500 mg (M) or clotrimazole (CL) vaginal cream, depending on aetiology of the infection, daily for 7 days (treatment phase) in a 2:1 ratio. A total of 45 women had a diagnosis of BV and 45 a diagnosis of VC. Sixty women were treated with CHX-VG, 15 with M and 15 with CL. All patients were followed for an additional 3 weeks without treatments (follow-up phase). For women with BV,clinical cure rate was defined as the disappearance of the following signs and symptoms: homogenous vaginal discharge; presence of >or= 2 or more clue cells at the wet mount microscopy; a vaginal pH > 4.7 and a positive whiff test. For women with VC, clinical cure rate was defined as a resolution of signs and symptoms plus absence of hyphae, pseudohyphae and blastospores on 10% KOH wet mount microscopy. Clinical cure rate was assessed at the end of the study (week 4) by an investigator unaware of the patient's treatment allocation.


RESULTS
At week 4, in women with BV, 28 out of 30 (93%) women in the CHX-VG group were clinically cured in comparison with 11 out of 15 (74%) in the M group (p = 0.3). In women with VC, 26 out of 30 (86.6%) women in the CHX-VG group were clinically cured in comparison with 13 out of 15 (86%) in the CL group (p = 0.5). Tolerability was good and very good in 90% of the CHX-VG patients. Six women (10%) complained of a mild transient burning sensation after CHX-VG vaginal application. No serious adverse events were observed during the trial in all treated groups. No women presented with vaginal discharge after treatment.
Molteni
Bruno
B
Obstetric and Gynecology Department 'Ospedale Civile', Giussano, Italy.
D'Antuono
Antonietta
A
Bandini
Patrizia
P
Sintini
Giuseppe
G
Barcellona
Eliana
E
Agnello
Antonella
A
Milani
Massimo
M
D000328:Adult; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy*; D002710:Chlorhexidine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007558:Italy; D008875:Middle Aged; D011247:Pregnancy; D011446:Prospective Studies; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use*; D016585:Vaginosis, Bacterial / Q000188:drug therapy*
D014622:Vaginal Creams, Foams, and Jellies; D002710:Chlorhexidine