Evaluation of menstrual bleeding patterns: a new proposal for a universal guideline based on the analysis of more than 4500 bleeding diaries

Abstract

Objective To develop a universal guideline allowing the comparison of interventions like oral contraceptives and hormone replacement therapy with an impact on menstrual bleeding pattern.

Methods Literature analysis and cluster analysis of 4612 bleeding diaries.

Results We summarized key definitions needed for the evaluation of menstrual bleeding patterns from the literature. We developed a methodology to systematically evaluate menstrual bleeding patterns that distinguishes between cyclical and continuous hormonal regimens.

Conclusion This universal guideline can be applied to all prospective clinical studies that affect menstrual bleeding patterns. It allows regulatory agencies and prescribing physicians to make meaningful comparisons of different products.

Key words:

• Bleeding pattern
• Cycle control
• Guideline
• Cluster analysis
• Contraceptive
• Hormone replacement therapy
• Endometriosis