title: Why nonoxynol-9 may have failed to prevent acquisition of Neisseria gonorrhoeae in clinical trials.
abstract: OBJECTIVE
  To understand why clinical trials failed to demonstrate efficacy of nonoxynol-9 in preventing gonorrhea.
  
  
  OBJECTIVE
  To test the hypothesis that nonoyxnol-9 failed to prevent acquisition of Neisseria gonorrhoeae because most isolates are resistant to killing by nonoyxnol-9 at the level attainable with intravaginal use.
  
  
  METHODS
  The lowest concentrations of nonoxynol-9 required to kill or inhibit growth of clinical isolates of N gonorrhoeae and Lactobacillus were determined.
  
  
  RESULTS
  Most strains (17 of 25) of N gonorrhoeae (68%) were resistant to the highest concentration of nonoxynol-9 tested (20%). L crispatus (100%), L jensenii (90%), and L iners (79%) were also resistant to nonoxynol-9.
  
  
  CONCLUSIONS
  N gonorrhoeae and H2O2-producing strains of vaginal lactobacilli were not killed by nonoxynol-9 at concentrations greater than those achievable in vivo. Earlier studies that formed the basis for subsequent trials most likely did not detect resistance because too few isolates were evaluated. Large numbers of clinical isolates should be examined before the initiation of clinical trial using microbicidal products.
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, and the Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, PA 15213-3180, USA. bjm4@pitt.edu
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Moncla
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Hillier
mesh_terms: D002986:Clinical Trials as Topic; D024881:Drug Resistance, Bacterial; D005260:Female; D006069:Gonorrhea / Q000453:epidemiology / Q000209:etiology / Q000382:microbiology* / Q000517:prevention & control*; D006801:Humans; D007778:Lactobacillus / Q000187:drug effects; D008826:Microbial Sensitivity Tests; D009344:Neisseria gonorrhoeae / Q000187:drug effects*; D017137:Nonoxynol / Q000494:pharmacology* / Q000627:therapeutic use; D010414:Pennsylvania / Q000453:epidemiology; D012107:Research Design; D013089:Spermatocidal Agents / Q000494:pharmacology* / Q000627:therapeutic use; D014626:Vaginal Smears
chemical_list: D013089:Spermatocidal Agents; D017137:Nonoxynol