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. 2003 Apr 22;2003(2):CD000218. doi: 10.1002/14651858.CD000218
Methods Random allocation to three groups.
No details of randomisation procedure given.
Placebos were used for the no‐treatment group.
No mention of blind outcome assessment.
Participants Women with trichomoniasis, >18 years, in Italy.
Exclusion criteria: patients with serious metabolic or systemic disorders and women who were treated for vaginal infections in the last 4 weeks.
Interventions Three groups: Fenticonazole, 600 mg single intravaginal ovule versus fenticonazole 1000 mg single intravaginal ovule versus placebo.
No mention of any partner treatment or notification.
Outcomes Presence of infection on day 4.
Clinical cure was assessed by the women (w) and physicians (p) separately using a semi‐quantitative scale (symptoms (w)/vaginal erythema and oedema (p): none, mild, moderate, severe). Side effects.
Notes Diagnosis was made by wetmount smear.
All women were asked to come for a second follow up visit on day 8; those who were Trichomonas positive on day 4 were given an additional 600 mg ovule regardless of their allocated group.
No mention of exclusions or loss to follow up.