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

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. 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 ≥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 ≥50% reduction in MBL), proportion with MBL below 80 mL and proportion with ≥50% reduction in MBL from baseline. Results: At study end, 63.6% and 11.9% of patients were successfully treated with E ₂V/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 ≥50% (all p<.001). Conclusion: E₂V/DNG is highly effective for the treatment of HMB and is associated with a high rate of treatment success.