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.


CONCLUSIONS
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.
Gerlinger
C
C
Clinical Statistics Europe, Bayer Schering Pharma AG, Berlin, Germany. Christoph.Gerlinger@bayerhealthcare.com
Endrikat
J
J
Kallischnigg
G
G
Wessel
J
J
D003271:Contraceptive Agents, Female / Q000009:adverse effects / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D005260:Female; D017408:Guidelines as Topic; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000706:statistics & numerical data*; D006801:Humans; D008499:Medical Records; D008598:Menstruation / Q000187:drug effects* / Q000502:physiology; D008599:Menstruation Disturbances / Q000139:chemically induced / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D013997:Time Factors; D014944:World Health Organization
D003271:Contraceptive Agents, Female