title: Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide.
abstract: OBJECTIVE
  We sought to determine the safety and acceptability of vaginal gel formulation PC-503 among low risk, abstinent women. The active ingredient was 2% pharmaceutical grade lambda carrageenan, a sulphated polymer that is generally recognised as safe by the US Food and Drug Administration.
  
  
  METHODS
  35 women in five sites applied 5 ml of the PC-503 gel vaginally once a day for 7 days while abstaining from sexual intercourse. Visual vaginal examinations were performed on days 1, 4, and 8. STI testing and vaginal pool Gram stain preparations were done on days 1 and 8. Participants were asked about product acceptability.
  
  
  RESULTS
  34 of the 35 women enrolled completed 7 days' use. Following product use, five reported mild symptoms including "bladder fullness," "genital warmth," or discomfort, and lower abdominal pain, and one had moderate pale yellow cervical discharge. Using the Nugent criteria, three women had bacterial vaginosis (BV) before and after use; three had BV before but not after, and two had BV after but not before. Most of the women found PC-503 to be pleasant or neutral in feel and smell and considered extra lubrication to be an advantage; however, one third found it to be messy.
  
  
  CONCLUSIONS
  Vaginal use of PC-503 gel did not cause significant adverse effects in a small number of low risk, sexually abstinent women. Further testing in larger numbers of sexually active women is planned. A smaller volume of gel may be more acceptable to some women.
authors.affiliation: Population Council, New York 10017, USA.
authors.forename: C
authors.initials: C
authors.lastname: Coggins
authors.forename: K
authors.initials: K
authors.lastname: Blanchard
authors.forename: F
authors.initials: F
authors.lastname: Alvarez
authors.forename: V
authors.initials: V
authors.lastname: Brache
authors.forename: E
authors.initials: E
authors.lastname: Weisberg
authors.forename: P H
authors.initials: PH
authors.lastname: Kilmarx
authors.forename: M
authors.initials: M
authors.lastname: Lacarra
authors.forename: R
authors.initials: R
authors.lastname: Massai
authors.forename: D
authors.initials: D
authors.lastname: Mishell
authors.forename: A
authors.initials: A
authors.lastname: Salvatierra
authors.forename: P
authors.initials: P
authors.lastname: Witwatwongwana
authors.forename: C
authors.initials: C
authors.lastname: Elias
authors.forename: C
authors.initials: C
authors.lastname: Ellertson
mesh_terms: D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects; D002351:Carrageenan / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D017060:Patient Satisfaction; D012749:Sexually Transmitted Diseases / Q000188:drug therapy*; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000891:Anti-Infective Agents, Local; D014622:Vaginal Creams, Foams, and Jellies; D002351:Carrageenan