Document Detail

Updated pregnancy rates for the Today contraceptive sponge.
MedLine Citation:
PMID:  3318467     Owner:  NLM     Status:  MEDLINE    
Pregnancy rates (method and user) were evaluated for 2245 women who participated in the phase III clinical trials of the Today contraceptive sponge. User and method pregnancy rates were similar for women of different ages and parities. The 1-year method and user pregnancy rates (life table per 100 women) were 8.2 and 5.6, respectively.
Phase III clinical trials of the Today contraceptive sponge, begun in 1979, have accumulated pregnancy rate data on 2245 women from 26 clinics. The overall, cumulative 12-month pregnancy rate is 13.3/100 women. The 172 pregnancies in this series were classified as either user or method failures on the basis of information in the case report forms and coital logs as well as from comments provided by the sponge acceptors and their physicians. The pregnancy rate for the 103 method failure was 8.2/100, while the pregnancy rate for the 69 user failures was 5.6/100. User and method pregnancy rates were similar for women of different ages and parities. The overall, cumulative pregnancy rate for a subset of 88 US women who participated in studies for a second year of use was 3.4/100. These results indicate that the Today sponge provides women with an adequate level of protection against pregnancy regardless of their age or parity. Some of the method failures occurring in the study population may have been due to a failure to adequately wet the sponge before insertion. This step is necessary in order to activate the release of spermicide.
D A Edelman; B B North
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  American journal of obstetrics and gynecology     Volume:  157     ISSN:  0002-9378     ISO Abbreviation:  Am. J. Obstet. Gynecol.     Publication Date:  1987 Nov 
Date Detail:
Created Date:  1987-12-18     Completed Date:  1987-12-18     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370476     Medline TA:  Am J Obstet Gynecol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1164-5     Citation Subset:  AIM; IM; J    
Medical Research Consultants, Inc., Chapel Hill, NC 27514.
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MeSH Terms
Clinical Trials as Topic
Contraceptive Agents, Female
Contraceptive Devices, Female*
Reg. No./Substance:
0/Contraceptive Agents, Female

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