Vaginosis, Bacterial Clinical Trial
Official title:
Phase I Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases
lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy
volunteering women and left in place for 7 days. The primary objective of this phase I study
is to assess the safety and the tolerability of this new intravaginal delivery system.
The eventual goal of this and related studies is to develop a vaginal ring that reduces
recurrences in women suffering from bacterial vaginosis, which is the commonest form of
vaginal infection.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
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