A New, Potentially Safer Birth Control Pill

On April 16, 2021, the US Food and Drug Administration approved Nextstellis, a new oral contraceptive (OC) that combines a novel estrogen, estetrol, with the well-known progestin drospirenone. (Full disclosure: The University of Florida receives research funding from the manufacturer, and in past years I have been a consultant to the company.) The new OC contains 14.2 mg of estetrol and 3 mg of drospirenone, the same amount of drospirenone found in other, commonly prescribed OCs.

Almost all currently prescribed OCs are formulated with ethinyl estradiol, a synthetic and highly potent estrogen. In contrast to ethinyl estradiol, estetrol is naturally occurring, and the estetrol used in the new OC is produced from a plant source. An earlier clinical trial found that an OC formulated with estetrol and drospirenone had substantially less impact on coagulation markers than an ethinyl estradiol-drospirenone or an ethinyl estradiol-levonorgestrel OC.

Recent phase 3 clinical trials conducted in North America and in Europe have found that the estetrol-drospirenone combination OC has contraceptiveefficacy comparable with that of current OCs and is well tolerated, having a bleeding profile similar to familiar, current OCs. In the phase 3 trials, the new estetrol-drospirenone OC had minimal impact on triglyceride, cholesterol, or glucose levels.