Case Study

Phase 3 Bacterial Vaginosis Study

Source: Health Decisions Inc.
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Ensuring that studies meet the business goals of sponsors and increase the range of treatment options available to patients and healthcare providers can be challenging when a trial must enroll subjects with a bothersome health condition and ask them to risk randomization to placebo, especially when effective treatments are available and study participation imposes potentially burdensome requirements. The project team in a study of an investigational treatment for bacterial vaginosis addressed such challenges and enabled the study to meet the sponsor’s goals.

This three-arm, double-blind, placebo-controlled, randomized study evaluated an investigational drug versus an active comparator and placebo in females ≥18 years of age with bacterial vaginosis. The study enrolled 876 subjects at 44 US sites and had 3 visits: screening and randomization, posttreatment assessment and test of cure.

Continue reading to learn how this study surmounted enrollment and retention challenges and succeeded in collecting data to support the statistical analysis.