Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest

作者：Fraser Ian S; Jensen Jeffrey; Schaefers Matthias; Mellinger Uwe; Parke Susanne; Serrani Marco^*

来源：Contraception, 2012, 86(2): 96-101.

DOI：10.1016/j.contraception.2011.11.011

• Estradiol valerate/dienogest
• Heavy menstrual bleeding
• Oral contraceptive
• Menstrual blood loss

Background: The study was conducted to assess the efficacy of estradiol valerate/dienogest (E2V/DNG) administered using an estrogen step-down and progestogen step-up approach in a 28-day regimen in the treatment of heavy menstrual bleeding (HMB) using clinical end points allowing E2V/DNG to be compared with other available medical therapies. %26lt;br%26gt;Study Design: This was a pooled analysis of data from two identically designed randomized, placebo-controlled, multiple center studies conducted in Europe, Australia and North America that assessed the effectiveness of E2V/DNG in reducing menstrual blood loss (MBL) in women with HMB. Women aged %26gt;= 18 years with objectively confirmed HMB were randomized to E2V/DNG (n=220) or placebo (n=135) for seven treatment cycles. Outcomes analyzed included absolute reduction in MBL from baseline, proportion of women successfully treated (defined as MBL below 80 mL and %26gt;= 50% reduction in MBL), proportion with MBL below 80 mL and proportion with %26gt;= 50% reduction in MBL from baseline. %26lt;br%26gt;Results: At study end, 63.6% and 11.9% of patients were successfully treated with E2V/DNG and placebo, respectively, with 68.2% and 15.6% of women with MBL below 80 mL, and 70.0% and 17.0% with MBL reduction %26gt;= 50% (all p%26lt;.001). %26lt;br%26gt;Conclusion: E2V/DNG is highly effective for the treatment of HMB and is associated with a high rate of treatment success.

• 出版日期2012-8