It may not surprise you to hear that earlier last week, Bayer Pharmaceuticals announced the release of their much anticipated and novel combined oral contraceptive pill, Natazia. With a name that sounds more like a Disney princess than a hormone-controlling drug, don't be surprised if the first image that comes to your mind is that of three or four fit and tanned 20-somethings water dancing in a pool or frolicking through a flowered meadow. Like breakthroughs in the tampon industry, birth control advances make us want to rejoice, do cartwheels on the beach, and paint pretty pictures with bright colors on large art canvases, right? That's what the commercials would have you believe, anyway.
But this time it's different, suggested a Bayer press release. Until now, all combined hormonal birth control methods sold in the United States--pills, the patch, even the ring--have differed only in their progestin components. The estrogen, in all of them, was the same--ethinyl estradiol. The same is not true for various other countries in Europe, who have been using the new, synthetic estrogen found in Natazia since 2009.
All this is about to change. On May 6, 2010 the Food and Drug Administration approved Natazia as the first ever birth control pill to use estradiol valerate in the United States. In combination with the progestin, dienogest, a synthetic progesterone with anti-androgenic (or anti-testosterone) properties, Natazia is expected to best other birth control pills in controlling heavy and prolonged menstrual bleeding.
In a study that gave women either Qlaira (the European version of Natazia) or placebo pills for 90 days, Bayer found that women on the true pill had decreased menstrual bleeding over all. The same could be said however, about a wealth of birth control pills and without closely examining the study in detail, it's difficult to know the pill's true implications on menorrhagia.
One of the main fallacies with the new pill is that researchers neglected to evaluate its efficacy in women with a BMI over 30. According to the Centers for Disease Control and Prevention, over 30-percent of all Americans are obese (defined as a BMI greater than 30). This means that for almost one-third of all U.S. women, Natazia hasn't been proven to work. And here's another surprising fact: birth control, in general, isn't expected to work as well in obese women. Natazia isn't the only pill that discourages physicians from prescribing to women with high BMIs. This is because combined hormonal contraceptives have been shown to increase the risk of cardiovascular disease (stroke especially) in obese women. It's not a discriminatory issue, it's a health issue, and a serious one at that.
So if you're not obese and willing to take a chance on a new, possibly revolutionary, type of pill, there don't appear to be too many drawbacks at the moment. Two large, multi-center phase three trials of Natazia found that the most common side effect was headache (at 13 percent). Less than two-percent of all 1,800 plus participants experienced side effects, some of which included irregular bleeding, breast pain or tenderness, nausea and vomiting, acne, and a slight weight increase. To find out more about Natazia, which Bayer plans to release later this summer, talk with your health care provider.
To read more about the fascinating world of contraception development and what all goes into creating breakthroughs like the ring, patch, IUD, and more, check out the following article on Slate.com.