Introduction: Two identically designed randomized, placebo-controlled double-blind studies (one conducted in North America and the other one in Europe and Australia) showed that an oral contraceptive containing estradiol valerate (E2V)/dienogest (DNG) in an estrogen step-down, progestogen step-up 28-day regimen was effective in women with heavy and/or prolonged menstrual bleeding without organic pathology. Both studies applied a strict definition of treatment success, based on a composite of eight individual criteria. To make these results comparable with published data, data were pooled and re-analyzed using a definition of successful treatment more commonly referred to in literature, applying more clinically meaningful criteria.
Methods: Women≥18 years with objectively-confirmed heavy menstrual bleeding (HMB, defined as menstrual blood loss (MBL) ≥80 ml/cycle in two cycles during a 90-day run-in period) without organic cause were randomized to E2V/DNG (n=220) or placebo (n=135) for 7 cycles of 28 days. MBL was measured objectively using the alkaline-hematin method. The primary variables were absolute change in MBL volume from baseline and proportion of women who were successfully treated at cycle 7. Treatment success was defined as MBL volume ≤80 ml and ≥50% reduction in MBL volume from baseline to cycle 7.
Results: At cycle 7, the proportion of patients with successful treatment was 63.6% with E2V/DNG and 11.9% with placebo (P<0.001). A MBL volume ≤80 ml was observed in 68.2 and 15.6% of women, respectively, and a MBL volume reduction ≥50% was observed in 70.0 and 17.0% of women, respectively (both P<0.001). From baseline to cycle 7, median MBL volume reduced from 179.8 to 35.7 ml with E2V/DNG, and from 174.9 to 163.7 ml with placebo (P<0.001 for E2V/DNG versus placebo).
Conclusions: E2V/DNG was highly effective for treating HMB and was associated with a high overall response rate.
30 Apr - 04 May 2011
European Society of Endocrinology