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[Letter concerning] public health message regarding which contraceptives provide protection against sexually transmitted diseases (STDs) and which do not.
[Unpublished] . 2 p.In 1983, the US Food and Drug Administration (FDA) informed various consumer groups that it now required manufacturers to note on certain contraceptive labels that the product does not protect against sexually transmitted diseases (STDs), including HIV infection. FDA also asked for help in communicating this message to others. The contraceptives include oral contraceptives (OCs), Norplant, Depo-Provera, and IUDs. FDA is in the process of reviewing scientific studies regarding spermicides, Today Sponge, cervical caps, and diaphragms before taking any action on the relabeling of these contraceptives. The modified information must be conspicuously displayed and must be clear, understandable to the consumer, and not overshadowed by other information. FDA has taken this action in an attempt to eliminate the confusion created by the information of previous labels and contraceptive packages concerning STDs and HIV transmission. Various consumer representatives and health professionals had informers FDA that this information confused people who practice risky sexual behavior, especially teenagers and young adults. Since 1987, FDA has recommended that natural-membrane condoms be labeled as inferior to latex condoms in providing protection against STDs. Individual latex condom wrappers and the outer packages not state: "If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other STDs. "The natural-membrane condom packages read: "This product is intended to prevent pregnancy. It does not protect against AIDS and other STDs. In order to help reduce the risk of infection of many STDs, including AIDS, use a latex condom." FDA requires almost identical labeling on packages for OCs, Norplant, Depo-Provera, and IUDs, but does not require the statement about using a latex condom.
Trip report: Honduras Contraceptive Social Marketing Program, Tegucigalpa, Honduras, June 11 - June 18, 1984.
Washington, D.C., Futures Group, International Contraceptive Social Marketing Progam, 1984. 25 p. (Project No. AID/DSPE-CA-0087)At the request of the International Contraceptive Social Marketing Project, Tennyson Levy of the Tritora Corporation visited Honduras in June, 1984, to assist the Honduras Contraceptive Social Marketing Project to conduct market research to assess the impact of a 5-week advertising program. The campaign was undertaken to launch the introduction of the program's 1st product, Perla, a standard dose oral contraceptive (OC). During the visit the consultant was asked to assist in the development of an advertising plan for all 4 products which will be distributed by the program. The other 3 products are 1) Prebien, a low dose OC; 2) Guardian, a condom; and 3) Sana, a vaginal tablet. The consultant also helped develop research to guide the development of appropriate packages for the Guardian and Sana products. The distribution of Perla began in March, 1984, and the media campaign was conducted during May, 1984. Monthly sales for March amounted to 5271 cycles, and for May, 11,256 cycles. The campaign consisted of 2 45-second radio spots which ran 30 times a day for a month and a press ad. A visit to 12 pharmacies in June to obtain feedback about the advertising campaign led to the conclusion that the campaign increased awareness of Perla, of how it could be obtained, and of how much it cost; however, the campaign did little to alter women's fears and misconceptions about OCs. Recommendations were made for conducting a 2-phase advertising campaign to further promote Perla. The 1st phase will begin immediately and run for 8 weeks. The objective of the 1st phase will be to address women's fears and misconceptions about OCs. The 2nd phase will run from September 1984-July 1985, and the objectives of this phase will be to promote Perla as a method to avoid pregnancies which might keep women from attaining their personal goals, to encourage married women to use Perla to space their births and to limit family size, and to protect unmarried women from the fear of an unwanted pregnancy. Specific messages and channels for disseminating the messages for each phase of the campaign were specified. Communication strategies for the other 3 products were also provided. Guardian messages will seek to equate the macho image with responsible behavior. The Prebien campaign will be directed toward 16-24 year olds, and the Sana compaign will stress that vaginal tablets are a convenient method for lactating women, for teenagers, and for women who engage in sexual activities infrequently. A research strategy for conducting market research throughout the 13-month advertising campaign was developed. A previously developed survey questionnaire for evaluating the advertising campaign was redrafted, and an appropriate sampling strategy for the survey was developed. Pertinent research topics were identified, and a research time table was proposed. An advertising budget was also developed. Funds currently available for the campaign (US$93,000) are inadequate, and additional funds must be requested. The radio spots used in the initial Perla campaign are included in the appendix.
[Unpublished] 1980. Presented at the International Family Planning Association Seminar for Pharmacists, Dublin, Ireland, January 30, 1980. 8 p.In this discussion of standards and quality control in contraception, attention is directed to the following: scope; effectiveness; spermicides; diaphragms; condoms; labeling; evaluation; and stage of testing. The oral contraceptive (OC) is 100% effective, and the condom is not 100% effective. Couples limiting their families tend to use OCs most carefully, while couples spacing their families tend to use condoms less carefully. To make a fair comparison between OCs and the condom, it is necessary to compare like with like. In a recent UK study of married women, the 1st year pregancy rate was 5% for OC, 11% for the condom, and 14% for the diaphragm. For women married since 1970, contracepting after their 1st or 2nd pregnancies, the pregnancy rate was 4% for OCs and only 5% for the condom. Combining a good quality condom with a compatible spermicide is theoretically as effective as OCs. In regard to spermicides, their laboratory testing may bear practically no relation to their contraceptive effectiveness. It is plausible to suppose that spermicides satisfying the former International Planned Parenthood Federation (IPPF) Agreed Test are more effective contraceptives than other spermicides. When last submitted, all spermicides widely available in the UK satisfied the former IPPF Agreed Test. There are few national standards on diaphragms and none on other caps. The International Organization for Standardization (ISO) is attempting to fashion an international diaphragm standard. There are many national condom standards and an ISO technical committee is on the way to an international condom standard. It is important to distinguish between so-called electronic testing which is applied to all condoms, and sample testing, which is the concern of condom standards. Electronic testing seeks to eliminate condoms with holes or weak spots. The sample testing esentially checks the efficiency of that process, which may vary widely. Immediatly after electronic testing, the British Standard (1979) prescribes a sampling frequency of 1%. From each production quantum of 10,000 condoms, 100 random samples are taken and inspected for visible defects. The same condoms are then tested for holes. The Swedish State Standard (1972) prescribes the same test for holes, performed on condoms sampled from every batch imported into Sweden. Different standards also prescribe somewhat different tests for condom strength. Most condom standards prescribe dimensions. There are various requirements on labeling, and some standards prescribe instructions on storage and use. 99.5% freedom from holes is achieved, yet the main cause of method failure is a burst condom. It is guessed that at least 1 in 1000 good quality condoms burst, yielding a pregnancy rate of about 0.3/100 woman years.
[Unpublished] 1982 Feb 22. 16 p.Family of the Future (FOF) conducted between December 14 1981 and January 7 1982 interviews with 394 people at 10 pharmacies and 3 clinics, to determine awareness of family planning methods. Among the 394 people interviewed 100 did not use contraception, 98 were condom users, 100 were oral contraceptive (OC) users, and 96 were vaginal foaming tablet users. Mean age of males was 34.7, and mean age of OC users was 31, of foaming tablet users was 30, and of nonusers was 28. In general, men were better educated than women. 44% of condom users said they liked them because of lack of side effects; 1/3 said the condom reduced sensitivity; 90% of users knew the Tops brand, followed by the Tahiti brand. 99% bought condoms at a pharmacy; 7 out of 10 would buy Tops; 4 out of 10 said they first bought a condom under advice of the pharmacist. 76% preferred the inner package to be covered on both sides; 2/3 of respondents said they had seen advertisements about Tops. 49% of OC users thought it was the most effective method; mean duration of pill use was 5.3 years. 33% had first heard of OCs from a doctor; 90% of users took the pill correctly and the most common side effect was headache. 50% of women said neither a doctor nor a pharmacist had ever discussed side effects with them. Anovlar was the best known brand, and 95% of users were satisfied with the brand they used. Users of tablets liked the lack of side effects best, although 6 out of 10 did not like the bubbly, warm, and burning sensation after insertion; 4 out of 10 users said their husbands could feel the tablet during intercourse. 90% of users had heard of the Amaan brand, and 82% currently used it. 9 out of 10 users bought the tablets at a pharmacy, and 90% said they had read the instructions; 4 out of 10 had heard of the tablets from a doctor. Among nonusers of contraception 3 out of 10 were pregnant, 2 out of 10 were breastfeeding, and 2 out of 10 said they wanted more children. 6 out of 10 had previously used the pill, 1/4 the IUD, and 20% the condom. Nonusers reported that they would start family planning in about 1 year. 6 out of 10 said they would use the IUD, 3 out of 10 the pill, and less than 10% the tablet. The pill was chosen because of its effectiveness, but prospective users knew they would experience some side effects. 90% of prospective IUD users also were expecting side effects. The IUD was chosen mostly because of its effectiveness and because it does not need sustained motivation. Over 90% of users would like more information about family planning methods; about 7 out of 10 respondents knew of FOF.
Family Planning Perspectives. 1983 May-Jun; 15(3):146-8.On April 1, 1983, the US Food and Drug Administration (FDA) approved a disposable vaginal sponge of soft polyurethane foam saturated with 1 gm of nonoxynol-9 as a nonprescription contraceptive offering 2 improvements over products already available: ability to leave in place up to 24 hours, and no need for additional application of spermicide for repeated acts of intercourse. Clinical tests show the sponge to be comparable in effectiveness to other vaginal methods including the diaphragm. Although no major medical complications have been detected in studies of the sponge thus far, concern over the possibility of its causing toxic shock syndrome led the FDA to require package labeling recommending that the product not be used during menstruation. The sponge was developed by the V.L.I. Corporation of California and will be marketed for about $1 under the brand name "Today." The sponge must be moistened with water before insertion to activate the spermicide, and is believed to prevent conception by releasing the spermicide over 24 hours, blocking the cervix to some extent, and absorbing sperm. The sponge has undergone 5 years of clinical testing in the US and abroad and is the 1st nonprescription contraceptive to go through the safety and efficacy tests required for prescription drugs and devices. Controlled, comparative tests conducted by the International Fertility Research Program began in 1979 in volunteers aged 18-40 who were randomly assigned to the sponge or another vaginal method. Available results are based on 1582 sponge users and 1579 controls. The data reviewed by the FDA advisory committee were based on 720 sponge users and a similar number of diaphragm users in the US segment. The 12-month pregnancy rates from the US trials were 15.8/100 women for the sponge and 11.6/100 women with the diaphragm, not a statistically significant difference. The US data suggest that about 4% of users will develop allergic reactions such as itching, irritation, and rash.
Washington, D.C., Futures Group, . 72 p. (Project No. AID/DSPC-CA-0087)This study of commercialization of contraceptives in Port-au-Prince, Haiti was conducted to generate information about packaging design, logos, names, colors, and prices that could influence potential users to buy contraceptives and to determine factors related to uses of methods that could influence their choices. Specific study objectives were as follows: determining certain characteristics of the market such as incidence of contraceptive use and user's age and socioeconomic class; determining the list of benefits sought by users and potential users of contraceptives, the ideal contraceptive, usage information, and incidence of selling price; identifying certain factors, i.e., needs, desires, opinions of present services; and determining preference for brand name, packaging design, logos, and colors of contraceptives. A total of 300 interviews were conducted--100 women for the oral contraceptives (OCs), 100 women for the foaming tablets, and 100 men for the condoms. The following were among the study findings: in general, all respondents were aware of 1 contraceptive method; from 100 interviewed, 82% knew about OCs, and 85% of the 82 were past users; 71% of the present OC users (49) purchased their pills at a pharmacy, and 21% preferred the Ortho Novum brand; 24% of the 82 ever users would prefer 2 cycles in a package, and the same percentage preferred more than 3 cycles; among the 100 interviewed regarding the condom, 68% were past users of a contraceptive method from which 74% (50) were condom users, and 69% were presently using the condom; in general, reasons given for using condoms were mainly easy availability, no side effects, no medical visit, and disease prevention; the benefits sought from the ideal condom were thin, resistant, inexpensive, and available by unit; among the 69% current condom users, 29 buy them in a pharmacy or small shop and most of them asked for Tahiti brand; respondents said they are willing to pay anything less than US$1 for good quality condoms (they indicated that Tahiti was "not good quality"); 70% of those interviewed about foaming tablets knew about this method, but only 20 respondents were past users of the tablets and 35 were actual users; most foam tablet dropouts considered the method inefficient; reasons given by respondents for having chosen foaming tablets were recommended by relative or friends and do not require daily utilization; and 66% of foaming tablet users bought their products in a pharmacy.
Irvine, California, VLI Corporation, Professional Relations Department, 1983 Jun. 9 p.A new vaginal contraceptive sponge (Today) successfully completed the US Food and Drug Administration NEW DRUG review process for safety and efficacy on April 1, 1983. The Today sponge will be marketed as an over-the-counter drug. The product consists of a resilient, hydrophilic, polyurethane foam sponge impregnated during manufacture with nonoxynol-9 (N-9), a spermicide in use worldwide for over 20 years. N-9 has been classified as safe and effective by the FDA Advisory Review Panel on OTC Vaginal Contraceptives. Contraception with the Today sponge occurs by: 1) spermicidal action of N-9, 2) sperm absorption into the sponge, and 3) blockage of the cervix. The principal advantage of the Today contraceptive sponge, aside from being available without prescription, is that it separates the act of contraception from that of intercourse, thus permitting for the 1st time, sexual spontaneity with a vaginal contraceptive. Multiple coital episodes are possible with a single sponge. Preclinical USP toxicity studies, mutagenicity assays, allergenic response tests, microbiological studies, and human clinical trials conclusively show no evidence of a significant health risk. The product was found in laboratory tests to be hostile to the growth of Staphylococcus aureas, suspected in the etiology of Toxic Shock Syndrome (TSS). Clinical trials with the Today contraceptive sponge, however, were not large enough to assess the risk of developing TSS. Particular attention has been directed to demonstrating safety with respect to carcinogenicity and mutagenicity. Assays for monomers have continually shown the finished product sponge and the polymeric sponge alone to lack any concerns in this area. These assays are conducted on a continuing basis through a formal stability program now in its 3rd year. This stability program includes accelerated testing at both high and low temperatures for up to 3 months, which has confirmed a lack of product degradation. Further, and most significantly, the product has been subjected to a stringent series of carcinogenicity and mutagenicity screens consisting of both the Ames Salmonella Mutagenicity Test and the Mouse Lymphoma Forward Mutation Assay. These tests have been conducted by both Huntingdon Research Center and Litton Bionetics, and have been successfully passed by the Today sponge in every instance. Phase I trials beginning in 1977 (100 women) demonstrated general acceptability and led to improvements in contraceptive capability. Phase 2 clinical trials beginning in 1978 (400 women) produced a cumulative 6-month life-table pregnancy rate of 5.98/100 women; the protocol called for 1 month use of a single sponge with reuse/washing permitted for a maximum of 10 washings. Phase 3 randomized comparative trials (1600 women) began in 1979 and are ongoing internationally and in the US. This protocol calls for a single sponge use for up to 48 hours wear time. Data to date indicate that sponge effectiveness is in the same range as other vaginal contraceptives. Analysis of the outcome of pregnancies during and after use of the sponge indicates no teratologic or embryologic effects. Of the 719 women in the US studies, 1.7% discontinued because of itching, irritation, rash; 1.9% discontinued because of allergic reactions. These results are consistent with the normal allergenic reactions experienced with the use of N-9. Since insufficient numbers of women in the Phase 3 studies chose to use the sponge for a full 48 hour period, statistical analysis of effectiveness data permits only a single day use recommendation. Thus, in the US, users are instructed to rely on the sponge for pregnancy prevention no longer than 24 hours and to leave the sponge in place at least 6 hours after the last episode of coitus. (author's modified)