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

Ian S. Fraser, Jeffrey Jensen, Jeffrey T. Jensen, Matthias Schaefers, Uwe Mellinger, Susanne Parke, Marco Serrani
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

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 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). CONCLUSION: E₂V/DNG is highly effective for the treatment of HMB and is associated with a high rate of treatment success.

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MeSH descriptors

Androgens Estradiol Estrogens Menorrhagia Nandrolone Adolescent Adult Androgens Androgens Androgens Contraceptives, Oral, Combined Contraceptives, Oral, Combined Contraceptives, Oral, Combined Contraceptives, Oral, Combined Contraceptives, Oral, Hormonal Contraceptives, Oral, Hormonal Contraceptives, Oral, Hormonal Contraceptives, Oral, Hormonal Double-Blind Method Drug Combinations

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