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FDA Provides Trial Advice for Bacterial Vaginosis Drugs in Guidance

July 19, 2016

The FDA is recommending that companies conducting clinical trials on bacterial vaginosis drugs exclude patients with herpes simplex or human papilloma virus, one of dozens of recommendations the agency made on the subject.

Patients receiving antibacterial therapy that is unrelated to bacterial vaginosis also should be excluded, according to a draft guidance, which gives multiple recommendations on inclusion criteria and trial considerations.

Trials should involve two randomized, double-blinded tests that are either placebo-controlled or active-controlled, both of which operate under the hypothesis that the investigational drug is superior to the control treatment. The guidance recommends that participants keep a diary on the drug’s administration, symptom assessments and adverse events.

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