Treatment of heavy menstrual bleeding with a new combination of estradiol valerate and dienogest

Luis Bahamondes, Ilza Monteiro, Arlete Fernandes
Human Reproduction Unit, Department of Obstetrics and Gynecology, School of Medical Sciences and National Institute of Hormones and Women’s Health, University of Campinas, Campinas, Brazil

Abstract: The first combined oral contraceptive (OC) was launched in the US 50 years ago and was followed by another formulation introduced in Germany one year later. The most common estrogen component in current formulations is ethinylestradiol; however, many concerns have been raised with respect to this estrogen. Although the natural estrogen produced by the ovary, 17-beta estradiol, is the most potent of the estrogens, it is poorly absorbed orally, and previous attempts to use it in combined OCs have been unsuccessful due to the occurrence of irregular bleeding. Recently, a new combined OC was developed containing a natural estrogen, estradiol valerate, and a new progestin, dienogest, in a dynamic 26-day, four-phasic (estrogen stepdown and progestin stepup) scheme of administration. In clinical trials, its contraceptive performance was excellent, with good cycle control and bleeding patterns compared with other combined OCs or with placebo. This review focuses predominantly on the use of an estradiol valerate-dienogest combined OC for the treatment of heavy menstrual bleeding. The findings of two large, randomized, controlled trials have shown that this combined OC constitutes an effective treatment for women with heavy menstrual bleeding, representing a new therapeutic option to reduce menstrual blood loss. Further studies are necessary to confirm these data.

Keywords: dienogest, estradiol valerate, heavy menstrual bleeding, menorrhagia, contraception