FDA Approves Four-Phasic Natazia

Speaking of the Pill's 50th anniversary, the FDA just approved a new combination oral contraceptive pill, Natazia (Qlaira in Europe), the first four-phase oral contraceptive marketed in the United States.

Three things you should know about Natazia:

1. Uses New Estrogen/Progestin combination.

Natazia is the first and only oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in a woman’s body....

Until today, all marketed combination oral contraceptives (COCs) contained ethinyl estradiol. With the FDA approval of Natazia, Bayer HealthCare Pharmaceuticals becomes the first company to launch estradiol valerate together with the progestin, dienogest.

So, Natazia contains the estrogen estradiol valerate and the progestin dienogest; the other COCs contain the estrogen ethinyl estradiol and various progestins like, for example, levonorgestrel.

2. Dosing Is Four-phasic.

Four-phasic means the doses of estrogen and progestin vary four times throughout each 28-day dosing cycle, like so:

  • 2 dark yellow tablets each containing 3 mg estrogen
  • 5 medium red tablets each containing 2 mg estrogen and 2 mg progestin
  • 17 light yellow tablets each containing 2 mg estrogen and 3 mg progestin
  • 2 dark red tablets each containing 1 mg estrogen
  • 2 white placebo tablets (inert)

Two things to note. First, the placebo interval is reduced to only 2 days. Second, you have 4 days (2 at the beginning and 2 at the end of the active cycle) when you're only taking estrogen pills.

3. It's New.

So, will Natazia's 4-phasic dosage provide the solution to all your past Pill use woes? Eh, I wish, but most likely no. Natazia is just a different Pill brand, not necessarily better or worst than existing brands. How well you do on it will depend on your personal history. Although I haven't seen any data so far to that effect, my guess on what's behind this new dosage regimen is that Bayer will try to gear this brand to the menstrual disorders demographic.