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A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe.
Contraception. 2007 Nov; 76(5):389-99.C

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.

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.

Authors+Show Affiliations

Department of Ob/Gyn, University of California San Francisco, Women's Global Health Imperative, San Francisco, CA 94105, USA. avdstraten@globalhealth.ucsf.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

17963865

Citation

van der Straten, Ariane, et al. "A Randomized Controlled Safety Trial of the Diaphragm and Cellulose Sulfate Microbicide Gel in Sexually Active Women in Zimbabwe." Contraception, vol. 76, no. 5, 2007, pp. 389-99.
van der Straten A, Napierala S, Cheng H, et al. A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe. Contraception. 2007;76(5):389-99.
van der Straten, A., Napierala, S., Cheng, H., Mauck, C., Depineres, T., Dhlakama, P., Thompson, M., Chipato, T., Hammond, N., & Padian, N. (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.
van der Straten A, et al. A Randomized Controlled Safety Trial of the Diaphragm and Cellulose Sulfate Microbicide Gel in Sexually Active Women in Zimbabwe. Contraception. 2007;76(5):389-99. PubMed PMID: 17963865.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe. AU - van der Straten,Ariane, AU - Napierala,Sue, AU - Cheng,Helen, AU - Mauck,Christine, AU - Depineres,Teresa, AU - Dhlakama,Patricia, AU - Thompson,Marin, AU - Chipato,Tsungai, AU - Hammond,Nii, AU - Padian,Nancy, Y1 - 2007/09/21/ PY - 2007/06/14/received PY - 2007/07/09/revised PY - 2007/07/18/accepted PY - 2007/10/30/pubmed PY - 2008/2/8/medline PY - 2007/10/30/entrez SP - 389 EP - 99 JF - Contraception JO - Contraception VL - 76 IS - 5 N2 - 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. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/17963865/A_randomized_controlled_safety_trial_of_the_diaphragm_and_cellulose_sulfate_microbicide_gel_in_sexually_active_women_in_Zimbabwe_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(07)00351-4 DB - PRIME DP - Unbound Medicine ER -