Protocol Summary: Cellulose sulfate (CS) was an antimicrobial and contraceptive agent. This study was designed with three arms: 1) diaphragm with 6% CS gel; 2) diaphragm with KY gel and; 3) CS gel alone. Participants were instructed to use their assigned study product before every sex act for a period of six months. Safety endpoints were assessed monthly by questionnaires and urinanalysis, and bi-monthly through clinical examinations, colposcopy, wet mounts, and gram stains.
Years: 2000 – 2003
Investigator: Tsugai Chipato, MBChB, FRCOG, MCE
Location: Spilhaus CRS
van der Straten A, Napierala S, Cheng H, Mauck C, Depineres T, et al. (2007) A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe. Contraception; 76(5): 389-99.