Objective: To perform a phase IV, open-label study of OVULE (Personal Care Products, Skillman, New Jersey) using magnetic resonance imaging (MRI) to describe the release, vaginal distribution and retention of a suspension containing miconazole nitrate in healthy female volunteers.
Study design: Three parous and 3 nulligravid women were enrolled. Each subject self-inserted the OVULE on the MRI table and remained recumbent after insertion. MRI images were obtained every 15 minutes for 1 hour and then at predetermined intervals following suspension insertion until the suspension was no longer identified.
Results: Placement of the OVULE was in the upper vagina in 4 subjects and in the lower vagina in 1 subject, and the Ovule was expelled in 1 subject. Average time to capsule shell dissolution was 36 minutes. Average time to maximum vaginal mucosal coverage by the suspension was 49 minutes. The average time at which the suspension was last seen in the vagina was 5 hours and 53 minutes.
Conclusion: MRI can be used to noninvasively quantify the intravaginal spread of a therapeutic antifungal agent. Understanding the intravaginal spread of antifungal agents may lead to further optimization of antifungal preparations as well as to better patient instructions.