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
2011

Effective Treatment for Heavy Menstrual Bleeding

Sample size: 421 publication 10 minutes Evidence: high

Author Information

Author(s): Ian S Fraser, Susanne Parke, Uwe Mellinger, Andreas Machlitt, Marco Serrani, Jeffrey Jensen

Primary Institution: University of Sydney

Hypothesis

Does oestradiol valerate/dienogest effectively reduce menstrual blood loss in women with heavy and/or prolonged menstrual bleeding without organic pathology?

Conclusion

E2V/DNG was more effective than placebo in reducing menstrual blood loss in women with heavy and/or prolonged menstrual bleeding without organic pathology.

Supporting Evidence

  • Median menstrual blood loss decreased by 88% with E2V/DNG compared to 24% with placebo.
  • 83% of investigators rated symptom improvement in the E2V/DNG group compared to 40.6% in the placebo group.
  • Significant improvements in iron metabolism parameters were observed in women treated with E2V/DNG.

Takeaway

This study shows that a new pill can help women who bleed a lot during their periods feel better by making their bleeding much less.

Methodology

Women aged ≥ 18 years with heavy and/or prolonged menstrual bleeding were randomised to E2V/DNG or placebo for 196 days, with menstrual blood loss assessed using the alkaline haematin method.

Potential Biases

Potential bias due to the double-blind design and reliance on self-reported data for menstrual bleeding.

Limitations

The study may not be generalizable to all populations due to the specific inclusion criteria and the nature of the trials.

Participant Demographics

The majority of participants were Caucasian, with a higher proportion of Black women in the North American study.

Statistical Information

P-Value

p<0.0001

Confidence Interval

95% CI −30.7, −13.6

Statistical Significance

p<0.0001

Digital Object Identifier (DOI)

10.3109/13625187.2011.591456

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