title: In vivo distribution of a vaginal gel: MRI evaluation of the effects of gel volume, time and simulated intercourse.
abstract: A microbicide is designed to coat the vaginal epithelium and prevent transmission of HIV. Complete coverage is desired for optimal protection. In vivo factors affecting coverage have not yet been studied. This randomized crossover trial evaluates the effect of gel volume and patient activity upon vaginal epithelial coating. Gynol II gel was mixed with a magnetic resonance imaging (MRI) contrast agent. Ten women self-inserted, on separate visits, 3 or 5 mL of gel and underwent serial MRI scanning both before and after simulated intercourse. Gel spread was dependent upon time and volume. There was modest spread during the first hour and greater spread 6 h after insertion. Five milliliters of gel resulted in statistically significantly greater coverage immediately following insertion, within the first 30 min and at 6 h after insertion. Simulated intercourse greatly enhances gel spread. After simulated intercourse, the distribution of the gel at each volume was similar. Less leakage of gel was reported with the smaller volume.
authors.affiliation: Center for Reproductive Medicine and Surgery, University of Pennsylvania Medical Center, Philadelphia, PA 19104, USA. kbarnhart@mail.obgyn.upenn.edu
authors.forename: Kurt Thomas
authors.initials: KT
authors.lastname: Barnhart
authors.forename: E Scott
authors.initials: ES
authors.lastname: Pretorius
authors.forename: Kelly
authors.initials: K
authors.lastname: Timbers
authors.forename: David
authors.initials: D
authors.lastname: Shera
authors.forename: Mayadah
authors.initials: M
authors.lastname: Shabbout
authors.forename: Daniel
authors.initials: D
authors.lastname: Malamud
mesh_terms: D000328:Adult; D003075:Coitus; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004848:Epithelium / Q000187:drug effects; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D013089:Spermatocidal Agents / Q000008:administration & dosage*; D016896:Treatment Outcome; D014621:Vagina / Q000166:cytology / Q000187:drug effects* / Q000473:pathology; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage*
chemical_list: D013089:Spermatocidal Agents; D014622:Vaginal Creams, Foams, and Jellies