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Women Have More Natural Option With New Pill

by Heather Mayer, DOTmed News Reporter | May 12, 2010
FDA approval for
new contraceptive
Women have another option when it comes to choosing their oral contraceptive, but this time they can choose one that offers a natural estrogen hormone. The U.S. Food and Drug Administration recently approved Natazia, Bayer Healthcare Pharmaceutical's combination hormonal birth control pill.

"For the first time ever, [a woman has] her own natural estrogen," Anita Nelson, M.D., and professor of obstetrics and gynecology at the Harbor-UCLA Medical Center, told DOTmed News. "I kind of like that idea. We're able to offer the same level of safety and efficacy using hormones she's used to."

Unlike the traditional hormonal birth control pill, Natazia uses a synthetic estrogen hormone called estradiol velerate, which is converted into estradiol, a natural hormone, once it enters a woman's body, explained Nelson, who also spoke to Bayer for its Natazia statement.

In the past, it was impossible to use a natural estrogen that would be strong enough to work with progestin hormone, the "work horse" hormone that suppresses ovulation, said Nelson. Natazia's progestin hormone is called dienogest.

It was a matter of "recipe balancing," she said. "[Bayer] tried all kinds of combinations."

The final product, which is expected to be on the market this summer, consists of pills with varying doses of estradiol valerate and estradiol valerate in combination with dienogest, for certain days of the 28-day cycle.

This sliding dose scale, Nelson explained, allows women to only be without hormones for two days, as opposed to the traditional seven, which in some cases can cause unpleasant side effects.

"A lot of women have a lot of symptoms with conventional pills," she said. "Most pills these days shorten the pill-free interval."

But this pill, with its new recipe, isn't necessarily better than traditional pills, Nelson said. She pointed out that this wasn't a superiority test and there are no comparative studies.

"This [pill] was incredibly effective," she said. "And the light periods are very attractive."

This type of pill is new to the United States, but it's been a popular birth control option in Europe for several years, Nelson told DOTmed News. She pointed out that women tend to shy away from pills that are new, just out of their experimental stages.

"It's nothing women need to be afraid of," she said.

Natazia was evaluated in two multi-center, phase-3 clinical trials in North America and Europe, according to the FDA. The trials involved 1,867 women and nearly 30,000, 28-day treatment cycles.

Side effects are not unlike those found in traditional pills, including irregular bleeding, breast tenderness, headaches, nausea and vomiting, increased weight and acne, according to the FDA.

Read the May 2010 issue of DOTmed Business News, devoted to women's health, now online.