Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials

Bleeding patterns for the Liletta® levonorgestrel 52 mg intrauterine system

“…Lower dose levonorgestrel IUS products introduced to the market within the past decade have reported bleeding patterns using these criteria [4,5]. Standardised reporting of bleeding with contraceptive use has been endorsed for decades [1,6]. Yet, the current prescribing information for the three different doses of levonorgestrel IUS products (13.5, 19.5 and 52 mg) provides information in different ways, even among dose- Table 5.…”

“…IUS: intrauterine system. equivalent products [4][5][6][7][8]. As such, clinically relevant differences in bleeding patters are difficult to distill.…”

Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study

“…Furthermore, as an exploratory study, it was not formally powered for comparisons. Future analyses of bleeding data could benefit from the use of more standardized terminology, thus allowing for more direct comparison of data between studies [20]. Strengths of this investigation include the randomized, double-blind, double-dummy design, and the lack of any restriction on inclusion based on BMI, which is in line with current recommendations on the inclusion of women in combined hormonal contraceptive studies without restrictions on body weight [20].…”

A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study

“…Future analyses of bleeding data could benefit from the use of more standardized terminology, thus allowing for more direct comparison of data between studies [20]. Use of real-time electronic diary recordings could also improve the accuracy of data collection, and studies with larger groups of participants could benefit from stratification and analysis by prior patch use.…”