Efficacy and Tolerability of a New Chlorhexidine-Based Vaginal Gel in Vaginal Infections

Bruno Molteni; Antonietta D'Antuono; Patrizia Bandini; Giuseppe Sintini; Eliana Barcellona; Antonella Agnello; Massimo Milani


Curr Med Res Opin. 2004;20(6) 

In This Article


Bacterial vaginosis (BV) and vaginal candidiasis (VC) are the most common cause of leucorrhoea and vaginal infections in women.[1] It has been estimated that 50-75% of women will experience candidal vaginitis at some time in their lives.[8] BV may be the cause of up to half of cases of vaginitis in all women and the cause of from 10 to 30% of cases in pregnant women.[9] BV is associated with an increased risk of several conditions, including postoperative infection following hysterectomy.[10] Topical imidazoles and metronidazole or clindamycin are considered standard treatments of VC and BV 2,3 , respectively. However, concomitant bacterial vaginal infections are detected in up to half of women with vulvovaginal fungal infection.[4] Therefore the use of monotherapy with imidazoles or with an antibiotic was inappropriate in the case of mixed vaginitis. Chlorhexidine (CHX) is a wide-spectrum antibacterial and antifungal substance. It is utilised for prevention and treatment of infections, particularly of the oral cavity. In vitro and in vivo studies have shown that CHX is very effective against Candida albicans infections.[11,12] In obstetrics, CHX 0.25-0.5% vaginal douches are commonly used as an antiseptic treatment.[13] The use of CHX douches during labour, (every 4-6h) has shown to reduce peripartum infections and mother-to-child risk of transmission of Group B Streptococcus.[14] However, CHX douches efficacy could be limited by the short contact time with vaginal mucosa of this specific formulation. There are no data regarding efficacy and tolerability of CHX in the treatment of vaginal infections. So far no sustained-release CHX vaginal formulations have been available. CHX-VG is a new bioadhesive vaginal gel formulation, containing chlorhexidine 0.5%. This innovative formulation is characterized by a sustained release of CHX over time. The gel is able to release CHX in a constant and sustained manner for up to 13 h.[15]

Our results demonstrated, for the first time, that the use of a chlorhexidine-based bioadhesive vaginal gel is an effective treatment for both bacterial and fungal vaginal infections. The efficacy and the tolerability profile of this gel are comparable with the standard therapies commonly utilised in these conditions. However, some study limitations should be taken into account in evaluating our trial results. First the study was not a double-blind trial. However, the clinical assessments were performed by investigators unaware of patients' treatment allocations. In addition the efficacy of study treatments was assessed not only clinically, i.e. absence of signs and symptoms, but also by objective parameters such as vaginal pH and microscopic evaluations. The follow-up period in this study was only 4 weeks. Therefore, it is not possible to evaluate the efficacy of CHX-VG for longer follow-up periods (i.e. the efficacy of this new vaginal gel on recurrency rate of vaginal reinfections). However, in contrast to antibiotics commonly used in vaginal infections, vaginal chlorhexidine does not interfere with the normal lactobacilli-dominat vaginal flora.[16] This effect could be relevant in reducing the recurrency rate of re-infection after chlorhexidine treatment. However, further clinical trials are warranted to evaluate efficacy and tolerability of this new chlorhexidine vaginal gel in the long-term basis and in reducing recurrency rate of vaginal infections.


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