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

Authors

  • Ian S. Fraser University of Sydney, Sydney, New South Wales, Australia, Australia
  • Jeffrey Jensen Oregon Health & Science University, Portland, Oregon, United States, United States
  • Matthias Schaefers Bayer HealthCare Pharmaceuticals, Berlin, Germany, Germany
  • Uwe Mellinger Bayer HealthCare Pharmaceuticals, Berlin, Germany, Germany
  • Susanne Parke Bayer HealthCare Pharmaceuticals, Berlin, Germany, Germany
  • Marco Serrani Bayer HealthCare Pharmaceuticals, Berlin, Germany, Germany

DOI:

https://doi.org/10.18370/2309-4117.2014.17.110-116

Keywords:

estradiol valerate/dienogest, heavy menstrual bleeding, oral contraceptives, menstrual blood loss

Abstract

The study was conducted to assess the efficacy of estradiol valerate/dienogest (E₂V/DNG) administered using an estrogen step-down and progestogen stepup 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. 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. 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.

Author Biographies

Ian S. Fraser, University of Sydney, Sydney, New South Wales, Australia

Department of Obstetrics and Gynaecology

Jeffrey Jensen, Oregon Health & Science University, Portland, Oregon, United States

Department of Obstetrics & Gynecology

Matthias Schaefers, Bayer HealthCare Pharmaceuticals, Berlin, Germany

Global Clinical Development

Uwe Mellinger, Bayer HealthCare Pharmaceuticals, Berlin, Germany

Clinical Statistics

Susanne Parke, Bayer HealthCare Pharmaceuticals, Berlin, Germany

Global Clinical Development

Marco Serrani, Bayer HealthCare Pharmaceuticals, Berlin, Germany

Global Medical Affairs Women’s Health

References

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Published

2014-07-11

How to Cite

Fraser, I. S., Jensen, J., Schaefers, M., Mellinger, U., Parke, S., & Serrani, M. (2014). Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest. REPRODUCTIVE ENDOCRINOLOGY, (17), 110–116. https://doi.org/10.18370/2309-4117.2014.17.110-116

Issue

No. 17 (2014)

Section

Contraception

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Copyright (c) 2014 Ian S. Fraser, Jeffrey Jensen, Matthias Schaefers, Uwe Mellinger, Susanne Parke, Marco Serrani

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