NEW YORK, Nov 12 (Reuters Health) -- The female condom was approved for marketing and distribution by Japan's regulatory body, Koseisho, on Thursday, according to officials at the Chicago, Illinois-based Female Health Company.
Until the recent approval of oral contraceptives in Japan, male condoms were the primary method of contraception available in the country, company officials said in a press release. They estimate that the market for male condoms in Japan is about 600 million units and most of these condoms are purchased by women.
Approval of the female condom in Japan followed a 4-year development period that included a 10-center clinical trial conducted by Taiho Pharmaceutical, the company's Japanese partner. The findings suggest that the female condom can be 97% effective in preventing pregnancy.
"Positive results from our clinical trials showed that the female condom has a very favorable relative overall acceptability rating of 89%, so we are looking forward to a successful launch of this product in Japan," Tatsuo Watanabe of Taiho Pharmaceutical said. "We will now be able to provide women in Japan with another option when it comes to protecting themselves and their overall health."
The female condom, a polyurethane device manufactured in London, is currently the only available product controlled by women that in addition to preventing pregnancy, can also prevent HIV infection and other sexually transmitted diseases. The Female Health Company is also currently involved in a partnership with UNAIDS to expand access to the female condom to populations at risk.