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A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases.
N Engl J Med. 1998 Aug 20; 339(8):504-10.NEJM

Abstract

BACKGROUND

Nonoxynol 9 is a proved spermicide, but whether it is also a microbicide is uncertain. A truly effective vaginal microbicide would reduce the susceptibility of women to sexually transmitted diseases, including infection with the human immunodeficiency virus (HIV).

METHODS

We enrolled 1292 HIV-negative female sex workers in Cameroon and enrolled them in a double-blind, placebo-controlled study in which the participants were randomly assigned to use either a film containing 70 mg of nonoxynol 9 or a placebo film, inserted into the vagina before intercourse. All of the women were provided with latex condoms and were instructed to have their male sexual partners use them. At monthly follow-up visits, we examined the women with a colposcope for genital lesions, tested endocervical specimens for gonorrhea and chlamydia infection with DNA probes, tested for HIV infection, and treated the women for curable sexually transmitted diseases.

RESULTS

The rates of HIV infection (cases per 100 woman-years) were 6.7 in the nonoxynol 9 group and 6.6 in the placebo group (rate ratio, 1.0; 95 percent confidence interval, 0.7 to 1.5). The rates of genital lesions were 42.2 cases per 100 woman-years in the nonoxynol 9 group and 33.5 in the placebo group (rate ratio, 1.3; 95 percent confidence interval, 1.0 to 1.6). The rates of gonorrhea were 33.3 and 31.1 cases per 100 woman-years in the nonoxynol 9 and placebo groups, respectively (rate ratio, 1.1; 95 percent confidence interval, 0.8 to 1.4). The corresponding rates of chlamydia infection in the nonoxynol 9 group and the placebo group were 20.6 and 22.2 per 100 woman-years (rate ratio, 0.9; 95 percent confidence interval, 0.7 to 1.3). The women reported that condoms were used during 90 percent of sexual acts.

CONCLUSIONS

The use of a nonoxynol 9 vaginal film did not reduce the rate of new HIV, gonorrhea, or chlamydia infection in this group of sex workers who used condoms and received treatment for sexually transmitted diseases.

Authors+Show Affiliations

Epidemiology Unit, Family Health International, Durham, NC 27709, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

9709043

Citation

Roddy, R E., et al. "A Controlled Trial of Nonoxynol 9 Film to Reduce Male-to-female Transmission of Sexually Transmitted Diseases." The New England Journal of Medicine, vol. 339, no. 8, 1998, pp. 504-10.
Roddy RE, Zekeng L, Ryan KA, et al. A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases. N Engl J Med. 1998;339(8):504-10.
Roddy, R. E., Zekeng, L., Ryan, K. A., Tamoufé, U., Weir, S. S., & Wong, E. L. (1998). A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases. The New England Journal of Medicine, 339(8), 504-10.
Roddy RE, et al. A Controlled Trial of Nonoxynol 9 Film to Reduce Male-to-female Transmission of Sexually Transmitted Diseases. N Engl J Med. 1998 Aug 20;339(8):504-10. PubMed PMID: 9709043.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases. AU - Roddy,R E, AU - Zekeng,L, AU - Ryan,K A, AU - Tamoufé,U, AU - Weir,S S, AU - Wong,E L, PY - 1998/8/26/pubmed PY - 1998/8/26/medline PY - 1998/8/26/entrez KW - Acquired Immunodeficiency Syndrome--prevention and control KW - Africa KW - Africa South Of The Sahara KW - Biology KW - Cameroon KW - Case Control Studies KW - Chlamydia--prevention and control KW - Contraception KW - Contraceptive Agents--therapeutic use KW - Developing Countries KW - Diseases KW - Family Planning KW - French Speaking Africa KW - Genital Effects, Female KW - Genitalia KW - Genitalia, Female KW - Gonorrhea--prevention and control KW - Hiv Infections--prevention and control KW - Infections KW - Middle Africa KW - Nonoxynol-9--therapeutic use KW - Physiology KW - Reproductive Tract Infections KW - Research Methodology KW - Research Report KW - Sexually Transmitted Diseases KW - Spermicidal Contraceptive Agents--therapeutic use KW - Studies KW - Urogenital System KW - Viral Diseases SP - 504 EP - 10 JF - The New England journal of medicine JO - N Engl J Med VL - 339 IS - 8 N2 - BACKGROUND: Nonoxynol 9 is a proved spermicide, but whether it is also a microbicide is uncertain. A truly effective vaginal microbicide would reduce the susceptibility of women to sexually transmitted diseases, including infection with the human immunodeficiency virus (HIV). METHODS: We enrolled 1292 HIV-negative female sex workers in Cameroon and enrolled them in a double-blind, placebo-controlled study in which the participants were randomly assigned to use either a film containing 70 mg of nonoxynol 9 or a placebo film, inserted into the vagina before intercourse. All of the women were provided with latex condoms and were instructed to have their male sexual partners use them. At monthly follow-up visits, we examined the women with a colposcope for genital lesions, tested endocervical specimens for gonorrhea and chlamydia infection with DNA probes, tested for HIV infection, and treated the women for curable sexually transmitted diseases. RESULTS: The rates of HIV infection (cases per 100 woman-years) were 6.7 in the nonoxynol 9 group and 6.6 in the placebo group (rate ratio, 1.0; 95 percent confidence interval, 0.7 to 1.5). The rates of genital lesions were 42.2 cases per 100 woman-years in the nonoxynol 9 group and 33.5 in the placebo group (rate ratio, 1.3; 95 percent confidence interval, 1.0 to 1.6). The rates of gonorrhea were 33.3 and 31.1 cases per 100 woman-years in the nonoxynol 9 and placebo groups, respectively (rate ratio, 1.1; 95 percent confidence interval, 0.8 to 1.4). The corresponding rates of chlamydia infection in the nonoxynol 9 group and the placebo group were 20.6 and 22.2 per 100 woman-years (rate ratio, 0.9; 95 percent confidence interval, 0.7 to 1.3). The women reported that condoms were used during 90 percent of sexual acts. CONCLUSIONS: The use of a nonoxynol 9 vaginal film did not reduce the rate of new HIV, gonorrhea, or chlamydia infection in this group of sex workers who used condoms and received treatment for sexually transmitted diseases. SN - 0028-4793 UR - https://www.unboundmedicine.com/medline/citation/9709043/A_controlled_trial_of_nonoxynol_9_film_to_reduce_male_to_female_transmission_of_sexually_transmitted_diseases_ L2 - https://www.nejm.org/doi/10.1056/NEJM199808203390803?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -