title: A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe.
abstract: BACKGROUND
  Cellulose sulfate (CS) is an antimicrobial and contraceptive agent. We assessed its safety when used alone or with the diaphragm in Harare, Zimbabwe.
  
  
  METHODS
  This was a randomized controlled safety trial with three arms: diaphragm with 6% CS gel vs. diaphragm with KY gel vs. CS gel alone. Participants were instructed to use their study products before every sex act for a period of 6 months. Safety end points were assessed monthly by questionnaires and urinanalysis and bimonthly by clinical examinations, colposcopy, wet mounts and gram stains.
  
  
  RESULTS
  One hundred nineteen monogamous women were enrolled (28% HIV+) and 105 (88%) completed the study. No urinary tract infections were diagnosed during the study; 81.4% women had symptoms and/or signs of genital irritation considered at least possibly related to the gel or device, and 41.5% had changes in vaginal flora. There were no statistically significant differences between treatment groups in safety end points. All six women with deep epithelial disruption were diaphragm users, and all such findings were on the external genitalia. Of those, 4 had herpetic ulcers which were unrelated to products use.
  
  
  CONCLUSIONS
  Cellulose sulfate appeared safe when used for 6 months alone or with a diaphragm.
authors.affiliation: Department of Ob/Gyn, University of California San Francisco, Women's Global Health Imperative, San Francisco, CA 94105, USA. avdstraten@globalhealth.ucsf.edu
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
authors.forename: Sue
authors.initials: S
authors.lastname: Napierala
authors.forename: Helen
authors.initials: H
authors.lastname: Cheng
authors.forename: Christine
authors.initials: C
authors.lastname: Mauck
authors.forename: Teresa
authors.initials: T
authors.lastname: Depineres
authors.forename: Patricia
authors.initials: P
authors.lastname: Dhlakama
authors.forename: Marin
authors.initials: M
authors.lastname: Thompson
authors.forename: Tsungai
authors.initials: T
authors.lastname: Chipato
authors.forename: Nii
authors.initials: N
authors.lastname: Hammond
authors.forename: Nancy
authors.initials: N
authors.lastname: Padian
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002482:Cellulose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003274:Contraceptive Devices, Female / Q000009:adverse effects*; D005260:Female; D005831:Genital Diseases, Female / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D014621:Vagina / Q000382:microbiology; D015030:Zimbabwe / Q000453:epidemiology
chemical_list: D000890:Anti-Infective Agents; D002482:Cellulose; C020254:cellulose sulfate