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

Abstract Objective(s) To investigate the bleeding pattern and cycle control parameters of a contraceptive patch containing 0.55mg ethinyl estradiol (EE) and 2.1mg gestodene (GSD) compared with a patch containing 0.6mg EE and 6mg norelgestromin (NGMN). Study design In this phase III, open-label, randomized, parallel-group trial, healthy women aged 18–35 years (smokers aged 18–30 years) received either the EE/GSD patch ( n =200) or the EE/NGMN patch ( n =198). Treatment consisted of one patch per week for 3 weeks followed by a 7-day, patch-free interval for seven cycles. Bleeding control was assessed in two 90-day reference periods. Results In reference period 1, mean number of bleeding/spotting days was comparable across treatment groups (p>0.05). However, in reference period 2, there were fewer bleeding/spotting days in the EE/GSD patch group (15.7 versus 18.4; p Conclusion(s) Bleeding pattern and cycle control achieved with the EE/GSD patch was similar to that of the EE/NGMN patch. Implications statement The paper presents data on the bleeding pattern and cycle control parameters of an investigational transdermal contraceptive patch containing EE and GSD compared with an approved contraceptive patch containing EE and NGMN. This descriptive study found that bleeding patterns associated with the EE/GSD patch were similar to those of an EE/NGMN patch providing higher EE exposure.