Multi-center, open-label, randomized, parallel-group comparison of cycle control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal contraceptive patch containing 0.55 mg ethinyle...

Update Il y a 4 ans
Reference: EUCTR2008-007308-27

Multi-center, open-label, randomized, parallel-group comparison of cycle control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen vs. a comparator patch EVRA® (0.6 mg ethinylestradiol and 6 mg norelgestromin) in a 21-day regimen for 7 cycles in 400 women

Woman Man

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Extract

The primary objective is to investigate the bleeding pattern and cycle control parameters of the transdermal contraceptive patch FC Patch Low (material no. 80876395 containing 0.55 mg EE and 2.1 mg GSD) in comparison to the EVRA patch (containing 0.6 mg EE and 6 mg NGMN).


Inclusion criteria

  • Prevention of pregnancy