Noncontraceptive benefits of the estradiol valerate/dienogest combined oral contraceptive: a review of the literature

Abstract

Rossella E Nappi,1 Marco Serrani,2 Jeffrey T Jensen3 1Department of Obstetrics and Gynecology, Research Centre for Reproductive Medicine, IRCCS Policlinico San Matteo Foundation, University of Pavia, Pavia, Italy; 2Global Medical Affairs Women's Healthcare, Bayer HealthCare Pharmaceuticals, Berlin, Germany; 3Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, USA Abstract: Combined oral contraceptives formulated to include estradiol (E2) have recently become available for the indication of pregnancy prevention. A combined estradiol valerate and dienogest pill (E2V/DNG), designed to be administered using an estrogen step-down and a progestin step-up regimen over 26 days of active treatment followed by 2 days of placebo (26/2-day regimen), has also undergone research to assess the potential for additional noncontraceptive benefits. Randomized, placebo-controlled studies have demonstrated that E2V/DNG is an effective treatment for heavy menstrual bleeding – a reduction in median menstrual blood loss approaching 90% occurs after 6 months of treatment. To date, E2V/DNG is the only oral contraceptive approved for this indication. Comparator studies have also demonstrated a reduction in hormone withdrawal-associated symptoms in users of E2V/DNG compared with a conventional 21/7-day regimen of ethinylestradiol/levonorgestrel. Other potential noncontraceptive benefits associated with E2V/DNG, like improvement in dysmenorrhea, sexual function, and quality of life, are comparable with those associated with other combined oral contraceptives and are discussed further in this review. Keywords: heavy menstrual bleeding, hormone withdrawal-associated symptoms, quality of life