FDA prepares response to questions on sponge safety.
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The use-effectiveness and continuation rates of 4 methods of contraception were studied during a 2 year follow-up period in a group of 405 teenage girls. Results were compared in 2 groups of adolescents, 1 of highly motivated, high socioeconomic status girls (A) and 1 of poorly motivated, low socioeconomic status adolescent clinic patients (B). The method of contraception was selected by the girls, who were instructed in their proper use. Results showed good rates of continuation among girls of the 1st group as compared to those of the 2nd group. Pregnancy rates after 24 months of use, as calculated by Pearl's formula, was 3.6 and 5.4 respectively with the use of a condom, and 5.8 and 10.8 when the diaphragm was used. When using vaginal foam alone, the rates were 4.2 and 12.3 and with the rhythm method, 8.5 and 13.1. The foam-alone method was unpopular in both groups. No serious side effects or complications were recorded. The study demostrated a reasonable acceptability and use-effectiveness for barrier contraceptives. It is suggested that these harmless and complication-free methods, especially the condom and diaphragm, may be reasonable alternatives for the more modern methods in teens of all socioeconomic strata; an effort must be made to educate and instruct the poorly motivated and encourage them to present themselves for regular follow-up.
Lea's Shield is a new vaginal barrier contraceptive that may offer advantages over existing methods. It is made of silicone which is resistant to petroleum-based lubricants, does not absorb odors, and does not cause allergic reactions in users with latex sensitivity. It has an anterior loop for ease of insertion and removal and a one-way flutter valve. Its novel design has sufficient volume to fill the posterior fornix, which helps keep it in place and prevent sperm from entering the cervical os. This study evaluated with a standard postcoital test (PCT) the ability of the Lea's Shield used with spermicide or non-spermicidal lubricant to prevent sperm from entering midcycle cervical mucus. Ten sterilized women underwent four PCT cycles: one cycle in which no contraceptive barrier was used (a baseline cycle) and 3 cycles in which one of the following was used: Lea's Shield with spermicide, or with non-spermicidal lubricant, or the contraceptive diaphragm used with spermicide. All volunteers demonstrated more than 5 progressively motile sperm per high power field in the cervical mucus after intercourse in the baseline cycle. No motile sperm were found in the cervical mucus in any cycle in which Lea's Shield or the diaphragm was used with spermicide. No motile sperm were found in cervical mucus in 9 of 10 cycles in which Lea's Shield was used without spermicide. Only two progressively motile sperm were present in the cervical mucus of one volunteer who used the shield with non-spermicidal lubricant.(ABSTRACT TRUNCATED AT 250 WORDS)
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A literature review yielded no scientific basis for the currently accepted recommendations on the length of time spermicides used with diaphragms continue to kill sperm. Twelve volunteers provided 68 spermicide samples representing 6, 12, 18, and 24 hours of in vivo insertion in a contraceptive diaphragm using Ortho Creme, Gynol II, and vehicle controls. Testing for continued spermicidal effect was performed in the laboratory using quality semen from 2 donors and employing the Multiple Exposure Photography system of semen analysis. Results showed effective spermicidal action after 12 hours of insertion, mixed effectiveness after 18 hours, and poor effectiveness after 24 hours with both products, with Ortho Creme being more effective in the longer insertions. Placebo jelly enhanced sperm activity while placebo creme had a moderate inhibitory effect. Recommendations for further study are made.
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Data on the efficacy of vaginal contraceptive suppositories and foams available in the United States are reviewed, and data on a new vaginal contraceptive, the Collatex sponge, is presented. The efficacy of this device appears to be similar to that of the diaphragm.
The purpose of this study was to evaluate the safety, efficacy and acceptability of Lea's Shield, a new vaginal contraceptive barrier device, when used with either spermicidal or non-spermicidal lubricant. One-hundred-eighty-five (185) women enrolled at six centers. Half were randomized to use the device with spermicide and half with a non-spermicidal lubricant. To be eligible, volunteers had to be 18-40 years old (inclusive), in good health with regular menses, sexually active in an ongoing relationship and at risk for pregnancy, and willing to use Lea's Shield as their sole means of contraception for six months. Participants were seen at admission, one week, one month, three months and six months. Gross cumulative life table rates were calculated for pregnancy and others reasons for discontinuation. Adverse experiences and responses to an acceptability questionnaire were evaluated. One-hundred-eighty-two (182) volunteers contributed data to the analysis of safety and 146 to that of contraceptive efficacy. The unadjusted six-month life table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for non-spermicide users (p = 0.287). After controlling for age, center, and frequent prior use of barrier methods, the adjusted six-month life table pregnancy rate was 5.6 for spermicide users and 9.3 for non-spermicide users (p = 0.086), indicating that use of spermicide lowered pregnancy rates, although not significantly, during typical use. For purposes of comparison, it is important to note that this study differed from the cap/diaphragm and sponge/ diaphragm studies in that a high percentage (84%) of volunteers were parous. For reasons that are unclear, pregnancy rates among parous women using barrier contraceptives tend to be higher than among nulliparous women. Indeed, in this study there were no pregnancies among nulliparous users of Lea's Shield. Standardization of parity of this study population on those of the cap/diaphragm and sponge/diaphragm studies suggests that unadjusted pregnancy rates for this device would have been considerably lower (2.2 and 2.9 per 100 users of spermicide and non-spermicide, respectively) had the study been done using the populations of earlier studies. Since no directly comparative study has been done, these figures provide a tentative estimate of the relative efficacy of Lea's Shield compared with the sponge, cap, and diaphragm. There were no serious adverse experiences attributed to the use of Lea's Shield. Acceptability was very good. Seventy-five percent (75%) of women responded to an end-of-study questionnaire; 87% of these reported that they would recommend Lea's Shield to a friend. Lea's Shield is a new vaginal contraceptive that does not require clinician fitting. Pregnancy rates in this study compare favorably with other studies of barrier contraceptive methods including the cervical cap, diaphragm, and sponge, even though this study was done with greater rigor and with a greater percentage of parous women than previous barrier studies. Lea's Shield appears to be safe and very acceptable to study volunteers.
A trial of the contraceptive sponge was conducted at two clinics (403 subjects) in Yugoslavia. Women were periodically followed up for 1 year. The 1-year method pregnancy rate (life-table) was 5.6 per 100 women. Rates of other events leading to discontinuation of sponge use were similarly low. There were no serious complications. The results of the study show that the contraceptive sponge may be successfully used by a population of women with limited experience with the use of vaginal contraceptive methods.
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