Novel oral contraceptive for heavy menstrual bleeding: estradiol valerate and dienogest

Sally Rafie,¹ Laura Borgelt,² Erin R Koepf,³ Mary E Temple-Cooper,⁴ K Joy Lehman<sup>5

1</sup>Department of Pharmacy, University of California San Diego Health System, San Diego, CA, ²Departments of Clinical Pharmacy and Family Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, ³Department of Pharmacy Practice, University of New England College of Pharmacy, Portland, ME, ⁴Department of Pharmacy, Hillcrest Hospital, Cleveland Clinic, Mayfield Heights, OH, ⁵Department of Pharmacy, Ohio State University Medical Center, Columbus, OH, USA

Abstract: Abnormal uterine bleeding (AUB) is associated with significant direct medical costs and impacts both society and the quality of life for individual women. Heavy menstrual bleeding, a subset of AUB, also referred to as menorrhagia, is defined as menstrual blood loss greater than 80 mL or the patient's perception of excessive blood loss. The newest treatment option available is a novel combination oral contraceptive product containing estradiol valerate (E2V) and dienogest (DNG). As with other combination oral contraceptives, E2V/DNG works primarily by preventing ovulation. However, in contrast with other combination oral contraceptives, it is the progestin component of E2V/DNG that is responsible for endometrial stabilization. Use of E2V/DNG for six months has led to significant reductions in heavy menstrual bleeding with an average 65% reduction in mean blood loss. Approximately half of the women with heavy menstrual bleeding who received E2V/DNG for six months demonstrated an 80% reduction in mean blood loss. Additionally, significant improvements in hematologic indicators (ie, ferritin, hemoglobin, and hematocrit) have been shown. Based on its chemical properties, E2V/DNG may have fewer adverse effects on lipid and glucose metabolism and reduced risk of thromboembolic complications compared with other combination oral contraceptives. This has not yet been shown in clinical trials and until then it should be assumed that E2V/DNG has a safety profile similar to other combination oral contraceptives containing 35 µg or less of ethinyl estradiol. E2V/DNG has been compared with another combination oral contraceptive in healthy women without heavy menstrual bleeding and demonstrated improved bleeding patterns. E2V/DNG has not been compared with the levonorgestrel intrauterine device or other treatments for heavy menstrual bleeding. When compared with some other treatment options for AUB, E2V/DNG provides the added advantage of effective contraception.

Keywords: contraception, dienogest, estradiol valerate, Natazia^®, menstrual disorders, menorrhagia