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Obstetrics & Gynecology 2004;103:430-439
© 2004 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Contraceptive Effectiveness and Safety of Five Nonoxynol-9 Spermicides: A Randomized Trial

Elizabeth G. Raymond, MD, MPH, Pai Lien Chen, PhD and Joanne Luoto, MD for the Spermicide Trial Group*

From Family Health International, Research Triangle Park, North Carolina; and the National Institute of Child Health and Human Development, Rockville, Maryland.

Address reprint requests to: Elizabeth Raymond, MD, MPH, Clinical Research Division, Family Health International, P.O. Box 13950, Research Triangle Park, NC 27709; e-mail: eraymond{at}fhi.org.

OBJECTIVES: To estimate and compare the effectiveness and safety of 5 spermicides over 6 and 7 months of use, respectively. The spermicides included 3 gels containing 52.5 mg, 100 mg, and 150 mg of nonoxynol-9 per dose and a film and a suppository, each containing 100 mg of nonoxynol-9 per dose.

METHODS: Women wishing to use only spermicide for contraception for 7 months were randomly assigned to use 1 of the 5 spermicides with emergency contraception backup. Participants were followed up for up to 30 weeks after admission.

RESULTS: Of 1,536 women enrolled, 868 (57%) either relied on the spermicide for 6 months or became pregnant. The probability of pregnancy during 6 months of typical use of the spermicide was 22% (95% confidence limits 16%, 28%) in the 52.5-mg gel group, 16% (10%, 21%) in the 100-mg gel group, 14% (9%, 19%) in the 150-mg gel group, 12% (7%, 17%) in the film group, and 10% (6%, 15%) in the suppository group. The pregnancy risk in the 52.5-mg gel group was significantly different (P < .05) from that in either of the other gel groups. The pregnancy risks in the three 100-mg product groups were not significantly different (P = .35). No significant differences among groups were found in the 7-month probability of specified urogenital conditions.

CONCLUSION: The gel with the lowest amount of nonoxynol-9 was less effective than the 2 higher-dose gels. Among 3 products containing 100 mg of nonoxynol-9, formulation did not significantly affect pregnancy risk. All products were safe.

LEVEL OF EVIDENCE: I







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