Double-blind Randomized Placebo Controlled Trial of Oral Metronidazole in combination with either Vaginal Clindamycin or an Oestrogen-containing Vaginal Probiotic for the Treatment of Bacterial Vaginosis

Catriona Bradshaw PhD, MBBS (Hons)

To determine if addition of vaginal clindamycin or an oestrogen-containing vaginal probiotic, to recommended therapy for bacterial vaginosis (BV), oral metronidazole for 7 days, reduces 6-month recurrence rates. Three-arm randomised double-blind placebo-controlled trial of 450 women (150 per arm): [MetPlac] oral metronidazole (7days)/vaginal placebo (12 days), [MProb] oral metronidazole (7days)/vaginal probiotic (12 days) and [MetClin] oral metronidazole (7days)/vaginal clindamycin(1g 2% nocte,7 days). Symptomatic 18-50 year old females with BV on vaginal swab by the Nugent method were enrolled at Melbourne Sexual Health Centre, Australia. Participants underwent initial examination & STI screen and completed a detailed behavioural questionnaire at 0, 1, 2, 3 & 6 months.  At each interval participants were posted a kit containing swabs and a slide for self-collection and a questionnaire. Principle study outcome: Nugent score of 7-10. Cumulative BV recurrence rates were calculated and compared using Chi square and survival analyses using SPSS and STATA.

Disclosure of Interest Statement: This study was funded by the NHMRC. Authors have no potential conflicts of interest to declare with respect to this work.

2011 Australasian Sexual Health Conference 'Sex in the City', recorded in September 2011 Canberra, Australia.

Catriona Bradshaw
Catriona Bradshaw
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VideoDouble-blind Randomized Placebo Controlled Trial of Oral Metronidazole in combination with either Vaginal Clindamycin or an Oestrogen-containing Vaginal Probiotic for the Treatment of Bacterial VaginosisCatriona Bradshaw13'41"
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Catriona Bradshaw PhD, MBBS (Hons)

Senior staff specialist at Melbourne Sexual Health Centre with a PhD from the University of Melbourne and an honorary Senior Research Fellow at the Universities of Melbourne and Monash. Catriona is involved broadly in STI clinical and epidemiological research with a particularly interest in bacterial vaginosis and Mycoplasma genitalium. She has over 50 publications in peer reviewed scientific journals, is on the editorial board of Sexually Transmitted Infections and BMC Infectious Diseases and was the recipient of the 2007 L’Oreal Fellowship for Women in Science.

Co-authors: Pirotta M, Hocking JS, Garland SM, Morton A, De Guigand D, Fehler G, Morrow A, Walker S, Vodstrcil LA, Gurrin L, Fairley CK.
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