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. |
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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. |
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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. |
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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. |
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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. |