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New contraceptive drug gains US administrative approval


October 10, 2003

Saturday October 11, 2003

An "extended-cycle" oral contraceptive that reduces the number of periods from 13 to 4 per year has been approved the U.S. Food and Drug Administration. Clinical trials have found "SEASONALE" prevents pregnancy and has a comparable safety profile to a more traditional oral contraception. The new drug is designed to provide greater choice for women deciding on oral contraception and will be available on prescription in the States at the end of October 2003.

Barr Laboratories' SEASONALE is a a 91-day regimen taken daily as 84 tablets (0.15 mg levonorgestrel and 0.03 mg ethynyl estradiol) followed by 7 inactive tablets. Currently available oral contraceptives, which utilise the same well-established components, are based on a 28-day regimen.

A recently published Roper study cited in the Barr press release found that
when given the choice, nearly two-thirds of women would be interested
in reducing their number of periods to 4 times per year.

Barr also point out the when prescribing SEASONALE, the convenience of fewer periods should be weighed against the inconvenience of increased intermenstrual
bleeding and/or spotting.

It is estimated that more than 16 million women currently take oral contraceptives in the United States and in Australia 66.7% of all women used contraception according to ABS data from the mid-nineties, with the largest proportion - 40% - using the contraceptive pill.

About the Author
Mike Hanlon Mike grew up thinking he would become a mathematician, accidentally started motorcycle racing, got a job writing road tests for a motorcycle magazine while at university, and became a writer. As a travelling photojournalist during his early career, his work was published in a dozen languages across 20+ countries. He went on to edit or manage over 50 print publications, with target audiences ranging from pensioners to plumbers, many different sports, many car and motorcycle magazines, with many more in the fields of communication - narrow subject magazines on topics such as advertising, marketing, visual communications, design, presentation and direct marketing. Then came the internet and Mike managed internet projects for Australia's largest multimedia company, (Australia's largest Telco), (Australia's largest employment site),,, and a dozen other internet start-ups before founding Gizmag in 2002. Now he writes and thinks. All articles by Mike Hanlon
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