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2004 OCT 7 - (NewsRx.com & NewsRx.net) -- Instead, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted clearance to the company to market its personal lubricant product, Amphora.
In addition to its lubricating properties, the company said, Amphora has been shown, in early clinical and pre-clinical tests, to immobilize sperm for up to 8 hours when applied vaginally by women, and, in laboratory testing, to inactivate certain sexually transmitted infection (STI)-causing organisms including gonococci (gonorrhea), herpes, chlamydia, and HIV.
Teri Hirschfeld, Instead, Inc., said that while demonstrating the effectiveness of Amphora's microbicidal properties will require full-scale clinical trials that will take years to conduct, the company hopes to receive clearance to market a new contraceptive device using Amphora in the very near future.
"We are currently conducting tests combining Amphora with a version of our Instead Softcup," she explained. "This combination could provide women with a safe and discreet over-the-counter barrier contraceptive. Most importantly, it would put women in control [of their sexual health and contraception].
"We also believe that Amphora has the potential to replace N-9," Hirschfeld said.
N-9 (Nonoxynol-9) is currently the only available spermicide in the U.S., and has been shown in a report jointly published by the World Health Organization (WHO) and the Contraceptive ...