Carter-Wallace debuts new polyurethane condom in U.S.
Trojan Supra Microsheer joins Durex Avanti; others eye market
Beginning this month, U.S. condom users will have a choice in male polyurethane condoms when Carter-Wallace of Cranbury, NJ, introduces its first polyurethane condom, the Trojan Supra Microsheer. The Trojan condom joins the Durex Avanti manufactured by London International Group of London, England, as the only nonlatex synthetic male condoms now available in the United States. The sole condom for women, the Reality female condom from the Female Health Co. of Chicago, also is polyurethane.
More options are in store as Sensicon Corp. of Vista, CA, has obtained 510K approval from the U.S. Food and Drug Administration (FDA) for four styles of condoms made of synthetic thermoplastic elastomer. Mayer Laboratories of Oakland, CA, plans to follow this month’s Canadian launch of its polyurethane EZ*ON condom with a U.S. introduction sometime in 2000.
As the demand for condoms has grown as part of the safer-sex strategy to combat the spread of HIV/AIDS and other sexually transmitted diseases, so has the development of new synthetic styles of protection. Initial interest in nonlatex condoms was piqued by the concern for those men and women who have latex hypersensitivity. It is estimated that 1 to 2 million American men and women are allergic to latex.1
Condoms manufactured from polyurethane and other plastics are more resistant to deterioration and may enhance sensitivity, according to the current edition of Contraceptive Technology.2 And unlike latex, these condoms are compatible with oil-based lubricants.3
Now there are two choices
The Trojan Supra Microsheer is manufactured from a medical grade, high-performance elastomer polyurethane material, states Richard Kline, group vice president for the personal products marketing department of Carter Products, the Carter-Wallace division charged with condom sales. It has a flared-wall design with an integral ring at the open end, and contains a spermicidal lubricant. The condoms will be sold in both three- and six-count packages.
Carter-Wallace has received FDA clearance for two variations of the polyurethane condom: one lubricated with silicone, and the condom marketed as the Trojan Supra Microsheer, which is lubricated with silicone and the spermicide nonoxynol-9.4
The Trojan condom is manufactured through a dipping process of an aliphatic polyurethane material, which results in a condom that has a higher tensile strength and break force than a latex condom.4
The Durex Avanti entered the U.S. market in 1994 and is available in the United Kingdom, Italy, Germany, Holland, and the Nordic countries, according to Karen McInnes of London International Group’s corporate affairs department. The Avanti is available in one size and thickness and is sold in two- and five-condom packs.
U.S. availability of the Avanti is not widespread; some family planners still report problems in locating the product on local market shelves. The Internet has served as an alternate source of the Avanti, listed as a top seller on Condomania, the Web site for a Los Angeles-based retail business (http://www.condomania.com).
The FDA has cleared seven male synthetic condoms for marketing through its 510K substantial equivalence submission process, according to Jeff Grant, operations director for Sensicon Corp., a spin-off company from the former Tactyl Technol ogies, also in Vista, CA.
The seven condoms are the Avanti, the Trojan Supra Microsheer and a similar nonlubricated version, and four styles from Sensicon Corp.: a standard condom in both spermicidally lubricated and nonlubricated versions, a "baggy" condom, and a low-modulus/high elongation standard condom. All of the Sensicon condoms are manufactured from Tactylon, a nonlatex elastomer formulation of styrene ethylene butylene styrene.
Sensicon’s material has similar elastic properties to latex but is translucent when nonlubricated and clear when treated with a silicone lubricant. Sensi con condoms employ a vertical dipping manufacturing process and have a minimal rim at the open end.5 The company’s low-modulus/high-elongation condom is the focus of a contraceptive efficacy study funded by the National Institutes of Health in Bethesda, MD, and performed by the California Family Health Council in Los Angeles.
"We are about three-quarters of the way through that study," Grant says. "We are really excited with the results to date."
Findings published in 1992 show that the Sensicon Tactylon condom performs as well and is as acceptable to users as the latex condom.6 A similar comparison study by Family Health International, a Research Triangle Park, NC-based research firm, reflect slightly higher breakage rates for Tactylon condoms over the latex control.7
The FDA 510K approval allows condom companies to market new nonlatex condoms. How ever, all synthetic condoms are required to have an interim labeling step until the required extensive clinical trials on contraceptive efficacy are completed.5
The Durex Avanti entered the United States under the 510K approval process. Since that time, it has completed a contraceptive efficacy study. Results from the study show that while the Avanti compares well with a latex condom in terms of pregnancy prevention, it falls short when it comes to product performance. In 1,804 uses, the Avanti broke 66 times and fell off 22 times during intercourse, and it broke six times and fell off 60 times during withdrawal. In 1,882 uses, the control latex condom broke seven times and fell off three times during sex, and it broke once and fell off 20 times during withdrawal.8 (For a full review of the study, see Contraceptive Technology Update, October 1997, pp. 123-125.)
Sensicon will not divulge its timetable in bringing its products to market. The company is making sure it has all proper information in hand before it introduces its condoms, says Grant. Mayer Laboratories, now marketing its EZ*ON polyurethane condom in a number of European countries and entering the Canadian market this month, says it is considering entering the U.S. market as early as next year once it receives preliminary 510K approval, according to David Mayer, company president. A contraceptive efficacy trial on the EZ*ON condom has just entered the enrollment phase, he says.
Bi-directional donning
The EZ*ON is a thermal-formed condom manufactured from extruded polyurethane film. The condom was developed by Family Health International, with Mayer Laboratories acquiring worldwide rights for its manufacture, marketing, distribution, and sales in 1995. (Family planners may remember this condom as the PolyMAXX. See CTU, July 1996, pp. 77-79, for details.)
EZ*ON, with its bi-directional donning, is the first condom with no "wrong" side. It can be unrolled in both directions, and flanges located around the base of the condom allow it to be pulled onto the penis. It is lubricated with dimethylsiloxane, a nonspermicidal lubricant.
"We think that that increases the ease of donning the condom," says Mayer. "We also have found that it probably will reduce the damage or trauma to the condom by fingernails, jewelry, or something else."
The EZ*ON condom has met safety and conformity standards of the European Community Medical Device Directives, which allows it to be marketed in countries accepting such products. It is finishing a third breakage and slippage study to earn the FDA’s 510K approval, says Mayer.
References
1. U.S. Food and Drug Administration. Medical Device Alert (MDA91-1); March 1991.
2.Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th ed. New York City: Ardent Media; 1998.
3. Rosenberg MJ, Waugh MS, Solomon HM, et al. The male polyurethane condom: a review of current knowledge. Contraception 1996; 53:141-146.
4. Ohye GH. Trojan® Polyurethane Condom with Spermicidal Lubricant 510(k) Summary. Unpublished paper. U.S. Food and Drug Administration Center for Devices and Radiological Health; 1995.
5. McNeill ET, Gilmore CE, Finger WE, et al. The Latex Condom: Recent Advances, Future Directions. Research Triangle Park: Family Health International; 1997.
6. Trussell J, Warner DL, Hatcher R. Condom performance during vaginal intercourse: Comparison of Trojan-Enz® and TACTYLON® condoms. Contraception 1992; 45:11-19.
7. Steiner M, Joanis C, Taylor B, et al. Final Report — Functionality and Acceptability of Three Lubricated TACTYLON® Condoms and a Standard Lubricated Latex Condom. Durham, NC: Family Health International; 1993.
8. National Institute of Child Health and Human Development. Study of the Efficacy, Acceptability, and Safety of a Non-latex (Polyurethane) Male Condom. NIH Contract No. 1-HD-1-3109. Bethesda, MD; April 1, 1991-March 31, 1997.
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