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

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...

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Bibliographic Details
Published in:Reproductive sciences (Thousand Oaks, Calif.) Calif.), 2013-07, Vol.20 (7), p.745-754
Main Authors: Fraser, Ian S., Zeun, Susan, Parke, Susanne, Wilke, Baerbel, Junge, Wolfgang, Serrani, Marco
Format: Article
Language:English
Subjects:
Contraceptives, Oral - administration & dosage
Double-Blind Method
Drug Combinations
Embryology
Estradiol - administration & dosage
Estradiol - analogs & derivatives
Female
Follow-Up Studies
Humans
Internationality
Medicine & Public Health
Menorrhagia - diagnosis
Menorrhagia - drug therapy
Menorrhagia - epidemiology
Nandrolone - administration & dosage
Nandrolone - analogs & derivatives
Obstetrics/Perinatology/Midwifery
Original Article
Reproductive Medicine
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Summary: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.
ISSN:1933-7191
1933-7205
DOI:10.1177/1933719113477492