Treatment of heavy menstrual bleeding with the estradiol valerate and dienogest oral contraceptive pill

Abstract

The new estradiol valerate and dienogest oral contraceptive pill recently received U.S. Food and Drug Administration (FDA) approval to treat heavy menstrual bleeding in women without diagnosed uterine conditions.This oral contraceptive formulation combines estradiol valerate, which is metabolically identical to natural estradiol, with the potent new progestin, dienogest. The four-phasic pill is effective for pregnancy prevention and leads to significantly decreased menstrual bleeding among women with heavy periods, and shorter and lighter periods among women with normal periods. Studies indicate that this formulation may be associated with decreased hepatic activation compared to contraceptive pills that contain ethinyl estradiol. However, whether these findings translate to a decreased risk of thrombotic events has not been determined, and the pill carries the same contraindications as all other combined hormonal contraceptives.At least 10-15% of women suffer from heavy menstrual bleeding, defined as ≥80 mL of blood loss per cycle. In large clinical trials of women with heavy menstrual bleeding, the estradiol valerate and dienogest pill decreased blood loss volume by a median of 81%.Women with heavy menstrual bleeding treated with this contraceptive pill can expect a significant reduction in bleeding after just one cycle of use. This therapy leads to a decrease in bleeding that may be greater than that achieved by different oral contraceptive pills or other medical therapies, including tranexamic acid and nonsteroidal anti-inflammatory drugs.