Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials

Abstract This is the second of a two-article series describing the outcomes of the Hormonal Contraceptives Trial Methodology Consensus Conference held in Philadelphia, PA, on September 23, 2005. The first manuscript, “Hormonal Contraceptive Trials: Variable Data Collection and Bleeding Assessment Me...

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Bibliographic Details
Published in:Contraception (Stoneham) 2007, Vol.75 (1), p.11-15
Main Authors: Mishell, Daniel R, Guillebaud, John, Westhoff, Carolyn, Nelson, Anita L, Kaunitz, Andrew M, Trussell, James, Davis, Ann Jeanette
Format: Article
Language:English
Subjects:
Bleeding and/or spotting
Clinical trials
Combined hormonal contraceptives
Contraceptives, Oral, Combined - adverse effects
Contraceptives, Oral, Combined - therapeutic use
Contraceptives, Oral, Hormonal - adverse effects
Contraceptives, Oral, Hormonal - therapeutic use
Cycle control
Data analysis
Data Collection
Female
Humans
Metrorrhagia - chemically induced
Metrorrhagia - epidemiology
Obstetrics and Gynecology
Patient diaries
Reference Values
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Summary:Abstract This is the second of a two-article series describing the outcomes of the Hormonal Contraceptives Trial Methodology Consensus Conference held in Philadelphia, PA, on September 23, 2005. The first manuscript, “Hormonal Contraceptive Trials: Variable Data Collection and Bleeding Assessment Methodologies Influence Study Outcome and Physician Perception,” provided a description of methodologies applied in the US Food and Drug Administration medical officer's review of clinical trial data as contained in the Summary Basis of Approvals of New Drug Applications, results of the review and general conclusions. This manuscript provides recommendations regarding best practices in trial design, data collection and analysis regarding bleeding data in combined hormone contraception trials.
ISSN:0010-7824
1879-0518
DOI:10.1016/j.contraception.2006.08.012