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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe
Contraception, Volume 76, No. 5, Year 2007
Notification
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Description
Background: Cellulose sulfate (CS) is an antimicrobial and contraceptive agent. We assessed its safety when used alone or with the diaphragm in Harare, Zimbabwe. Study Design: 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. © 2007 Elsevier Inc. All rights reserved.
Authors & Co-Authors
van der Straten, Ariane
United States, San Francisco
University of California, San Francisco
Napierala-Mavedzenge, Sue Naperiela
United States, San Francisco
University of California, San Francisco
Cheng, Helen Y.
United States, San Francisco
University of California, San Francisco
Mauck, Christine K.
United States, Arlington
Conrad
DePiñeres, Teresa
United States, San Francisco
University of California, San Francisco
Dhlakama, Patricia Mae
Zimbabwe, Harare
University of Zimbabwe
Thompson, Marin
United States, San Francisco
University of California, San Francisco
Chipato, Tsungai
Zimbabwe, Harare
University of Zimbabwe
Hammond, Nii
Zimbabwe, Harare
University of Zimbabwe
Padian, Nancy S.
United States, San Francisco
University of California, San Francisco
Statistics
Citations: 27
Authors: 10
Affiliations: 3
Identifiers
Doi:
10.1016/j.contraception.2007.07.004
ISSN:
00107824
Research Areas
Infectious Diseases
Sexual And Reproductive Health
Study Locations
Zimbabwe
Participants Gender
Female