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

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.