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

Ian S. Fraser, Jeffrey T. Jensen, Matthias Schaefers, Uwe Mellinger, Susanne Parke, Marco Serrani
In: Contraception · 2012 · vol. 86(2) , pp. 96–101 · doi:10.1016/j.contraception.2011.11.011 · PMID:22240178 · W2028016880
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This study investigated the impact of an oral contraceptive containing estradiol valerate/dienogest on reducing blood loss in women experiencing heavy menstrual bleeding.

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Abstract

BackgroundThe 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 designThis 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.ResultsAt 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 ≥ 50% (all p<.001).ConclusionE₂V/DNG is highly effective for the treatment of HMB and is associated with a high rate of treatment success.

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