FDA Approves First 4-Phasic Oral Contraceptive

May 7, 2010 — The US Food and Drug Administration (FDA) has approved a combination hormonal contraceptive tablet containing estradiol valerate and dienogest (Natazia; Bayer HealthCare Pharmaceuticals).

The product offers 4 progestin/estrogen dosing combinations during each 28-day cycle and is the first "4-phasic" oral contraceptive to be marketed in the United States. It also is the first contraceptive to contain the bioidentical synthetic estrogen estradiol valerate, rather than ethinyl estradiol.

"Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives," said Scott Monroe, MD, director of the FDA's Division of Reproductive and Urologic Products, in an agency news release. "The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception."

FDA approval was based on data from 2 multicenter, open-label, single-arm phase 3 studies in which 1867 women with a body mass index of 30 kg/m² or less underwent nearly 30,000 treatment cycles in North America and Europe.

The Pearl Index (PI) was the primary measure for assessing contraceptive reliability, based on FDA criteria for pregnancies that occur in women aged 18 to 35 years during cycles 1 to 13, including pregnancies at 7 days posttreatment.

Results from the North America trial (3969 exposure cycles) and European trial (11,275 exposure cycles) showed contraceptive failure rates at 1 year of 0.016 (5 pregnancies; PI, 1.64) and 0.010 (9 pregnancies; PI, 1.04), respectively, which are similar to those of other hormonal contraceptives containing 20 μg ethinyl estradiol.

Adverse events most commonly (≥2%) reported with estradiol valerate/dienogest use included headache, including migraines (13.2%); metrorrhagia and irregular menstruation (8.0%); breast pain, discomfort, or tenderness (6.6%); nausea/vomiting (6.5%); acne (3.9%); and weight gain (2.8%).

As with other oral contraceptives, the safety labeling for estradiol valerate/dienogest strongly advises that women not smoke because of an increased risk for serious cardiovascular events that increases with age and number of cigarettes, particularly for those older than 35 years.

Estradiol valerate/dienogest contraceptive tablets (marketed as Qlaira) previously were approved for use in the European Union and are also being studied for the treatment of excessive, prolonged, and frequent menstrual bleeding.

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