A comparative study of Neo Sampoon, Ortho Vaginal Tablets and Emko Vaginal Tablets in Accra, Ghana. A comparative study of the safety, effectiveness and acceptability of two foaming vaginal tablets (nonoxynol-9 versus menfegol) in Thai women. Contraceptive effectiveness and safety of five nonoxynol-9 spermicides: a randomized trial. Contraceptive effectiveness of two spermicides: a randomized trial. Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial. A clinical trial of Neo Sampoon vaginal tablets and Emko foam in Alexandria, Egypt.
Neo Sampoon is an effervescent contraceptive vaginal tablet manufactured in Japan that contains 60 mg of the spermicide menfegol. Ortho Vaginal Tablets (OVT) and Emko Vaginal Tablets (EVT), both containing 100 mg of the spermicide nonoxynol-9, were manufactured in the USA. The three products were compared in a randomized clinical trial conducted at the family planning clinics of the Korle-Bu Teaching Hospital and the Kotobaabi Polyclinic in Accra, Ghana. Three-hundred volunteers participated. At 12 months, the life-table pregnancy rates were 9.6, 11.3 and 12.5 per 100 women in the Neo Sampoon, OVT and EVT groups, respectively (p greater than 0.10). More EVT than Neo Sampoon or OVT users discontinued because of discomfort as well as for other product-related reasons (p less than 0.01). The most common reason for discontinuation was the temporary absence of sexual partner, with more than 40% of the women overall terminating for this reason. The 12-month life-table continuation rates per 100 women were higher for the Neo Sampoon group (62.4) than the OVT group (48.6) or the EVT group (38.5) (p less than 0.01). The effectiveness of the three products seems to be similar, but Neo Sampoon and OVT appear to be more acceptable than EVT in this Ghanaian population. Two foaming vaginal tablets containing nonoxynol-9 (OVT-n) or menfegol (OVT-m) were studied to evaluate safety, effectiveness and acceptability. The study was conducted at the Chulalongkorn University, Institute of Health Research, Bangkok, Thailand. One-hundred-two women randomly assigned to one of the two types of tablets were scheduled for follow-up visits at 1, 3, 6 and 12 months. Although there were differences between the two groups in the gross cumulative 12-month life table rates and 12-month continuation rates, these differences were not statistically significant. Twelve-month discontinuation rates for accidental pregnancy were 31.7 per 100 women for OVT-n group and 25.3 per 100 women for the OVT-m group. Seventeen of the total 22 pregnancies occurred due to use failure. This study indicates that the regular and proper use of OVT-n or OVT-m tablets are comparable and are a safe means of birth control. Although a few product-related (burning) or medical complaints were reported by both groups of tablet users, it seems that the vaginal contraceptive is an acceptable method for fertility control in a suitable population who will use it regularly and properly. 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.
                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.
                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.
                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.
                I We conducted a multinational randomized trial to determine whether a spermicidal film containing 72 mg of nonoxynol-9 per film was at least as effective in preventing pregnancy as a foaming tablet containing 100 mg of nonoxynol-9 per tablet.
                Between September 1995 and July 1997, 765 women aged 18-35 years who had no evidence of subfecundity were randomly assigned to use one of the two spermicides as their only contraceptive method at every coital act for 28 weeks. Participants were asked to keep coital diaries throughout the study period. Pregnancy tests were performed on a scheduled basis. Each participant was followed for 28 weeks or until she stopped considering the spermicide as her primary method of contraception.
                The Kaplan-Meier estimate of the 6-month probability of pregnancy during typical use of the spermicide was 28.0% in the tablet group and 24.9% in the film group (P = .78, one-tailed test). The study had nearly 75% power to have detected a difference of seven percentage points between groups. Results were almost identical when the analysis included only months when the participants reported use of the spermicide during every coital act. Reported levels of sexual activity and compliance with use of the spermicide were high in both groups.
                The contraceptive effectiveness of these two spermicidal products appeared similar. Both products were associated with a fairly high risk of pregnancy in this young, highly sexually active population. 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 four centers located in three countries (two in Yugoslavia and one each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the two 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 six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users, based on data from the two 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. Results are reported for a comparative 12-month study of Neo Sampoon foaming vaginal tablets containing 60 mg of the spermicide, menfegol, and Emko vaginal foam containing an 8.0% concentration of the spermicide, nonoxynol-9. Conducted in cooperation with the Family Planning Association in Alexandria, Egypt, the trial included 349 women who were randomly allocated to use one of the two contraceptive products. The twelve-month cumulative life-table rate for accidental pregnancy (per 100 women) was 2.8 for Neo Sampoon tablet users and 2.1 for Emko foam users. The 12-month continuation rates were 77.6 and 77.2 per 100 women for the tablet and foam groups, respectively. In both groups, the majority of discontinuations from the study were for personal reasons, including lack of confidence in the method, messiness, partner's objection and a burning sensation. Few women reported a product-related complaint while using their assigned contraceptive method. The most commonly reported complaint for both methods was that use of the product led to an uncomfortable burning sensation for the woman and/or her partner. This complaint, however, was cited by less than 5% of the women in each group. Thus, a combination of low pregnancy rates, few complications and complaints and high continuation rates confirm the relative acceptability, effectiveness and short-term safety of these methods of contraception among this sample of Egyptian women.
The probability of pregnancy varied widely in reported trials. A gel containing nonoxynol-9 52.5 mg was inferior to two other products tested in the largest trial. Aside from this finding, personal characteristics and behavior of users may be more important than characteristics of the spermicide products in determining the probability of pregnancy. Gel was liked more than the film or vaginal suppository in the largest trial. Spermicide trials have the dual challenges of difficult recruitment and high discontinuation rates; the latter threatens trial validity.