By Deborah Brauser
ATLANTA -- October 22, 2009 -- An oral contraceptive consisting of oestradiol valerate/dienogest (E2V/DNG) decreases heavy menstrual blood loss (MBL) and is associated with improvements in iron metabolism parameters, according to a study presented here October 20 at the 65th Annual Meeting of the American Society for Reproductive Medicine (ASRM).
"Heavy menstrual bleeding is an important health problem for many women," said lead author Jeffrey T. Jensen, MD, Research Department of Ob/Gyn at the Oregon Health and Science University, Portland, Oregon. "The [currently] approved medical treatments are only marginally helpful."
For the study, Dr. Jensen and colleagues sought to evaluate the efficacy of E2V/DNG for patients with idiopathic heavy (>=80 mL, alkaline haematin method) and/or prolonged MBL (>=8 days.)
A total of 190 women aged 18 years or older without recognisable pelvic pathology were enrolled at centres in the United States and Canada and randomised in a 2:1 ratio to receive either E2V/DNG (n = 120) or placebo (n = 70) for 196 days, concluding with a 90-day efficacy phase.
Response rate, which was defined as "complete resolution of abnormal menstrual symptoms," was the primary outcome, while changes in MBL volume and iron metabolism were secondary.
Comparing the efficacy period with the run-in period, the response rate was significantly greater (P < .0001) for the women in the E2V/DNG group at 43.8% (95% confidence interval [CI], 32.7%-55.3%) versus 4.2% of those in the placebo group (2/51; 95% CI, 0.51%-14.3%).
In addition, the E2V/DNG-treated patients had a significantly greater mean MBL reduction at -353.1 mL versus -130.4 mL for those receiving placebo (P < .0001).
Not only was this decrease in MBL apparent from cycle 2, it was also accompanied by a significant increase in haemoglobin (+0.6 g/dL), haematocrit (+1.4%), and ferritin (+2.9 ng/mL) in the E2V/DNG-treated women. These improvements were not found in the placebo group.
"The dramatic improvement in the treated women was highly encouraging," said Dr. Jensen. "The biggest surprise was how quickly the treatment helped, as most women achieved a significant reduction in bleeding by 3 months."
"The number 1 take-away for clinicians is that an [oral contraceptive] containing E2V/DNG is a highly effective medical treatment for heavy or prolonged menstrual bleeding in women without other pathology," he summarised.
Funding for this study was provided by Bayer Schering Pharma AG.
[Presentation title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Oral Estradiol Valerate/Dienogest for the Treatment of Heavy and/or Prolonged Menstrual Bleeding. Abstract O-107]
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