A Randomized, Controlled Safety Trial of the Diaphragm and Cellulose Sulfate Microbicide Gel in Sexually Active Women in Zimbabwe

Sponsor: CONRAD

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

Non-Network

Completed Study

Publication:

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.

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