Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials.
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.
Mishell
Daniel R
DR
Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA. mishell@usc.edu
Guillebaud
John
J
Westhoff
Carolyn
C
Nelson
Anita L
AL
Kaunitz
Andrew M
AM
Trussell
James
J
Davis
Ann Jeanette
AJ
D003277:Contraceptives, Oral, Combined / Q000009:adverse effects* / Q000627:therapeutic use; D003278:Contraceptives, Oral, Hormonal / Q000009:adverse effects* / Q000627:therapeutic use; D003625:Data Collection; D005260:Female; D006801:Humans; D008796:Metrorrhagia / Q000139:chemically induced* / Q000453:epidemiology; D012016:Reference Values
D003277:Contraceptives, Oral, Combined; D003278:Contraceptives, Oral, Hormonal