Efficacy and tolerability of a new chlorhexidine-based vaginal gel in vaginal infections

SUMMARY

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

Study design and subjects: A total of 90 non-pregnant 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 ≥ 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.

Conclusion: These results demonstrate that in the short term, this CHX-VG is an effective treatment for both bacterial and mycotic vaginal infections. Further clinical trials are warranted to evaluate the efficacy and tolerability profile of this new chlorhexidine vaginal gel on a long-term basis and in reducing recurrency rate of vaginal infections.

Key words: :

• Chlorhexidine
• Randomised controlled trial
• Vaginal gel
• Vaginal infection