Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: pooled analysis of two multinational, randomised, double-blind, placebo-controlled trials of oestradiol valerate and dienogest

ABSTRACT

Objectives To evaluate the efficacy of oestradiol valerate/dienogest (E₂V/DNG) for the treatment of heavy and/or prolonged menstrual bleeding without organic pathology based on the analysis of data from two identically designed double-blind, randomised studies.

Methods Women aged ≥ 18 years with heavy and/or prolonged menstrual bleeding were randomised to E₂V/DNG (n = 269) or placebo (n = 152) for 196 days. Objective changes in menstrual blood loss (MBL) volume were assessed using the alkaline haematin method.

Results After six months of treatment, median MBL decreased by 88% with E₂V/DNG compared with 24% with placebo. The greatest reduction was achieved at the first withdrawal bleed after treatment initiation and it was sustained with no loss of effect throughout treatment.

Conclusion E₂V/DNG was more effective than placebo in reducing MBL in women with heavy and/or prolonged menstrual bleeding without organic pathology. The reduction was largely achieved as early as the first withdrawal bleed, with further gradual improvement throughout treatment.

KEYWORDS:

• Oral contraceptive
• Heavy menstrual bleeding

ACKNOWLEDGEMENTS

The authors would like to thank Jenny Szkolar and Danielle Turner of in Science Communications, a Wolters Kluwer business, for medical writing support during the preparation of this manuscript. Funding for this support was provided by Bayer Pharma AG, Berlin, Germany.

Declaration of interest and financial disclosures: Ian Fraser is a consultant and speaker for Bayer Pharma AG, Schering Plough and Daiichi Sankyo Pharmaceuticals and has received research support from the National Institutes of Health (NIH), the Australian National Health and Medical Research Council, the Population Council, Bayer Pharma AG and Schering Plough.

Susanne Parke, Uwe Mellinger, Andrea Machlitt and Marco Serrani are employees of Bayer Pharma AG.

Jeffrey Jensen has received payments for consulting and giving talks for Bayer Pharma AG, a company that may have a commercial interest in the results of this research and technology. This potential conflict of interest has been reviewed and managed by Oregon Health & Science University. He is also a consultant and speaker for Wyeth Pharmaceuticals and Schering Plough and has received research funding from Bayer Pharma AG, Wyeth Pharmaceuticals, Warner Chilcott, the Population Council, and the NIH.