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.
Acknowledgments
Medical writing support during development of this manuscript was provided by Mary Hines and Richard Glover of inScience Communications, Springer Healthcare. This assistance was funded by Bayer HealthCare Pharmaceuticals.
Disclosure
During the past 2 years, Dr Nappi had financial relationship (lecturer, member of advisory boards, and/or consultant) with Bayer HealthCare Pharmaceuticals, Ely Lilly, Gedeon-Richter, HRA Pharma, Merck Sharpe and Dohme, Novo Nordisk, Pfizer Inc., Shionogi Limited, and TEVA/Theramex. Dr Serrani is an employee of Bayer HealthCare Pharmaceuticals. Dr Jensen has received payments for consulting, from Agile Pharmaceuticals, Abbvie Pharmaceuticals, Bayer HealthCare Pharmaceuticals, ContraMed, Evofem Inc., HRA Pharma, Merck Pharmaceuticals, Teva Pharmaceuticals, and the Population Council; and for lectures, from Bayer and Merck; he has also received research funding from Abbvie, Bayer HealthCare Pharmaceuticals, the Population Council, the National Institutes of Health, and the Bill and Melinda Gates Foundation. These companies and organizations may have a commercial or financial interest in the results of this research and technology. The authors report no other conflicts of interest.