title: Use of mandelic acid condensation polymer (SAMMA), a new antimicrobial contraceptive agent, for vaginal prophylaxis.
abstract: OBJECTIVE
  To assess the contraceptive properties, antimicrobial activity, and safety of mandelic acid condensation polymer (SAMMA).
  
  
  METHODS
  Experimental study of SAMMA's in vitro and in vivo properties.
  
  
  METHODS
  Academic research laboratories.
  
  
  METHODS
  Healthy volunteers for semen donation in an academic research environment.
  
  
  METHODS
  Inhibition of sperm function indicators, conception, sexually transmitted infection-causing pathogens (including HIV), and lactobacilli was evaluated. Safety indicators were studied.
  
  
  METHODS
  Quantitation of SAMMA's effect on microbial infectivity or multiplication and on sperm function in vitro; evaluation of contraceptive efficacy in vivo; assessment of safety in vitro and in vivo.
  
  
  RESULTS
  Mandelic acid condensation polymer is not cytotoxic toward lactobacilli, microbial host cells, and spermatozoa. The compound inhibits hyaluronidase and acrosin, induces sperm acrosomal loss, and is contraceptive in the rabbit model. Mandelic acid condensation polymer prevents infectivity of HIV and herpesviruses 1 and 2 and, to a lesser extent, of Chlamydia trachomatis. It inhibits the multiplication of Neisseria gonorrhoeae. Mandelic acid condensation polymer is not mutagenic, has low acute oral toxicity, and is safe in the rabbit vaginal irritation assay.
  
  
  CONCLUSIONS
  Mandelic acid condensation polymer inhibits sperm function, is contraceptive, has broad-spectrum antimicrobial activity, and is highly safe. Further development as a microbicide is warranted.
authors.affiliation: Program for the Topical Prevention of Conception and Disease (TOPCAD), Department of Obstetrics and Gynecology, Rush University, Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, USA. lzanevel@rush.edu
authors.forename: Lourens J D
authors.initials: LJ
authors.lastname: Zaneveld
authors.forename: Robert A
authors.initials: RA
authors.lastname: Anderson
authors.forename: Xiao Hui
authors.initials: XH
authors.lastname: Diao
authors.forename: Donald P
authors.initials: DP
authors.lastname: Waller
authors.forename: Calvin
authors.initials: C
authors.lastname: Chany
authors.forename: Kenneth
authors.initials: K
authors.lastname: Feathergill
authors.forename: Gustavo
authors.initials: G
authors.lastname: Doncel
authors.forename: Morris D
authors.initials: MD
authors.lastname: Cooper
authors.forename: Betsy
authors.initials: B
authors.lastname: Herold
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000494:pharmacology*; D000890:Anti-Infective Agents / Q000494:pharmacology; D003270:Contraceptive Agents / Q000494:pharmacology*; D005260:Female; D006801:Humans; D017053:Infection Control / Q000379:methods*; D008297:Male; D008333:Mandelic Acids / Q000627:therapeutic use*; D011108:Polymers / Q000627:therapeutic use*; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D012449:Safety; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D013094:Spermatozoa / Q000187:drug effects; D014623:Vaginal Diseases / Q000517:prevention & control*
chemical_list: D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D003270:Contraceptive Agents; D008333:Mandelic Acids; D011108:Polymers; C468727:SAMMA