Dienogest versus ethinylestradiol/dienogest in patients with secondary dysmenorrhea due to clinical diagnosis of ovarian endometriosis: a multicentric, prospective, controlled study

Abstract

BACKGROUND Endometriosis is a common gynecological condition, affecting an estimated 10% of reproductive age women. Endometriosis can be a debilitating disease for women who experience painful symptoms such as dysmenorrhea, which may have a negative impact on the woman’s quality of life. There is no cure for endometriosis; management consists of alleviating pain and other symptoms, reducing endometriotic lesions and improving quality of life. While dienogest is a specific treatment for endometriosis, combined oral contraceptives like ethinylestradiol/dienogest are used off‐label for this pathology and contains estrogens despite the fact that endometriosis is an estrogen‐dependent disease. OBJECTIVES The aim of the study is to evaluate the efficacy of dienogest in contrast to ethinylestradiol/dienogest in secondary dysmenorrhea due to clinical diagnosis of ovarian endometriosis in order to find out if dienogest is more effective in reducing dysmenorrhea, intake of analgesics and endometrioma’s size, and in improving healthrelated quality of life compared to ethinylestradiol/dienogest. DESIGN A prospective, controlled, interventional and multicentric study. 264 patients from our reference ASSIR, will be divided in two groups, receiving with double‐blind and a randomized distribution of the sample, dienogest or ethinylestradiol/dienogest during 1 year, for the management of secondary dysmenorrhea due clinical diagnosis of ovarian endometriosis