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Improving the Objective Quality of Large-Scale Clinical Trials for Women With Heavy Menstrual Bleeding: Experience from 2 Multi-Center, Randomized Trials

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Abstract

This study demonstrates a robust and thorough trial design leading to accurate and objective data collection. We recommend that future studies investigating heavy menstrual bleeding (HMB) should follow, and improve upon, this rigorous approach to menstrual trial data collection, not only to validate clinical results but also to improve the techniques used to acquire these results. We propose that the state-of-the-art methodology described here be used as the basis for new guidelines for the implementation of clinical trials in the area of HMB.

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Authors and Affiliations

  1. University of Sydney and Sydney Centre for Reproductive Health Research, Family Planning NSW, 328–336 Liverpool Rd, Sydney, New South Wales, 2131, Australia

    Ian S. Fraser DSc

  2. Bayer HealthCare AG, Berlin, Germany

    Susan Zeun MD, PhD, Susanne Parke MD, PhD & Marco Serrani MD, PhD

  3. Laboratorium fu¨r Klinische Forschung, Schwentinental, Germany

    Baerbel Wilke MTA & Wolfgang Junge MD, PhD

Authors
  1. Ian S. Fraser DSc
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  2. Susan Zeun MD, PhD
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  3. Susanne Parke MD, PhD
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  4. Baerbel Wilke MTA
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  5. Wolfgang Junge MD, PhD
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  6. Marco Serrani MD, PhD
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Correspondence to Ian S. Fraser DSc.

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Fraser, I.S., Zeun, S., Parke, S. et al. Improving the Objective Quality of Large-Scale Clinical Trials for Women With Heavy Menstrual Bleeding: Experience from 2 Multi-Center, Randomized Trials. Reprod. Sci. 20, 745–754 (2013). https://doi.org/10.1177/1933719113477492

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  • DOI: https://doi.org/10.1177/1933719113477492

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