title: Safety and acceptability of 6% cellulose sulfate vaginal gel applied four times per day for 14 days.
abstract: BACKGROUND
  Six percent cellulose sulfate (CS) is a vaginal gel that has been in development as a microbicide.
  
  
  METHODS
  This was a single-center, multi-dose, Phase I, placebo-controlled, randomized, fully masked study conducted in Yaoundé, Cameroon, and involving sexually active women at low risk for sexually transmitted infections (STIs).
  
  
  METHODS
  The study assessed the effect of CS and K-Y Jelly applied vaginally four times per day, for 14 consecutive days, on genital epithelial disruption, candidiasis and bacterial vaginosis (BV). Acceptability of the products was also assessed. Twenty-seven women were enrolled in each treatment group.
  
  
  RESULTS
  Two (7.4%) of the women in each group developed genital epithelial disruption. One (3.7%) of the women in each group developed candidiasis, and one (3.7%) of the K-Y users developed BV. One (3.7%) of the CS users said she would not buy her product for pregnancy prevention but would for STI prevention. All the remaining women indicated they would buy their product for both indications.
  
  
  CONCLUSIONS
  The results suggest that the safety and acceptability of 6% CS gel are comparable to that of K-Y Jelly.
authors: l'Hôpital Gynéco Obstétrique et Pédiatrique de Yaoundé, Yaoundé, Cameroon.
authors: Anderson S
authors: AS
authors: Doh
authors: Nkele
authors: N
authors: Ngoh
authors: Ron
authors: R
authors: Roddy
authors: Jaim-Jou
authors: JJ
authors: Lai
authors: Kim
authors: K
authors: Linton
authors: Christine
authors: C
authors: Mauck
mesh_terms: D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects; D002181:Candidiasis, Vulvovaginal / Q000209:etiology; D002482:Cellulose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004848:Epithelium / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D014621:Vagina / Q000187:drug effects*; D014622:Vaginal Creams, Foams, and Jellies / Q000009:adverse effects; D016585:Vaginosis, Bacterial / Q000209:etiology
chemical_list: D000891:Anti-Infective Agents, Local; D014622:Vaginal Creams, Foams, and Jellies; D002482:Cellulose; C020254:cellulose sulfate