drugset / Trial / NCT00266032
Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
RandomizedParallel-groupOpen-labelPrevention
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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | drospirenone | Unknown | 3 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 20 ug | Oral |
Indications
No indication recorded.