Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial
Chi, I.C.; Smith, S.C.; Borko, E.; Sun, T.H.; Begum, S.F.; Hunt, W.L.; Wilkens, L.R.
Contraception 36(5): 499-514
1987
ISSN/ISBN: 0010-7824 PMID: 3329078 Document Number: 350437
This paper describes the results from a randomized clinical trial comparing the Collatex vaginal contraceptive sponge (a predecessor of the Today sponge) and Neo Sampoon foaming vaginal contraceptive tablets; the trial was conducted from 1979 to 1983 in 4 centers located in 3 countries (2 in Yugoslavia and 1 each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the 2 Asian centers. More Neo Sampoon users complained of a burning or stinging sensation. This complaint, however, seemed to be well-tolerated and was not a frequent reason for irregular use and/or discontinuation of use of the tablets. Clinically significant medical complications were rarely reported for either method. Sponge users were more likely to report irregular use than tablet users, primarily due to inconvenience of use. Rates of discontinuation at 6 months of use were also consistently higher among sponge users than Neo Sampoon users in the 4 centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2/100 sponge users and 6.2 to 29.9/100 Neo Sampoon users, based on data from the 2 Yugoslavian centers and the Taiwan center (data from the Bangladesh center were excluded from analysis of pregnancy rates). Practical implications of these findings are discussed.