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 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.

• Authors: Daniel R Mishell Jr, John Guillebaud, Carolyn Westhoff, Anita L Nelson, Andrew M Kaunitz, James Trussell, Ann Jeanette Davis
• Journal: Contraception (Contraception) Vol. 75 Issue 1 Pg. 11-5 (Jan 2007) ISSN: 0010-7824 [Print] United States
• PMID: 17161117 (Publication Type: Consensus Development Conference, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Contraceptives, Oral, Combined
• Contraceptives, Oral, Hormonal

Topics

• Contraceptives, Oral, Combined (adverse effects, therapeutic use)
• Contraceptives, Oral, Hormonal (adverse effects, therapeutic use)
• Data Collection
• Female
• Humans
• Metrorrhagia (chemically induced, epidemiology)
• Reference Values