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.
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.
Authors: Sue Kelly; Emyr Davies; Simon Fearns; Carol McKinnon; Rick Carter; Christoph Gerlinger; Andrew Smithers Journal: Clin Drug Investig Date: 2010 Impact factor: 2.859
Authors: Thomas Strowitzki; Thomas Faustmann; Christoph Gerlinger; Ulrike Schumacher; Christiane Ahlers; Christian Seitz Journal: Int J Womens Health Date: 2015-04-15