Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles

Summary

The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.

Timeline

Start

2005-12

Primary completion

2008-10

Completion

2008-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300) vs Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300); p <0.0001; Mean Difference (Final Values) -25 (95% CI -29 to -20); t-test, 2 sided NCT00266032 ↗

Publications

• Results Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Long-term tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):84-93. doi: 10.1136/jfprhc-2011-100214.
• Results Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Contraceptive efficacy and tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):73-83. doi: 10.1136/jfprhc-2011-100213.
• Results Reif S, Snelder N, Blode H. Characterisation of the pharmacokinetics of ethinylestradiol and drospirenone in extended-cycle regimens: population pharmacokinetic analysis from a randomised Phase III study. J Fam Plann Reprod Health Care. 2013 Apr;39(2):e1-13. doi: 10.1136/jfprhc-2012-100397.

Drugs

Indications

No indication recorded.