The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
12
vaginal ring containing no TMC120 (dapivirine)
vaginal ring containing 120 mg TMC120 (dapivirine)
Drug Research Unit, UZ Gent
Ghent, Belgium
safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
Time frame: 7 days
TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma
Time frame: 7 days
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