A Study of Efficacy and Safety With the Transdermal Contraceptive System.
|ClinicalTrials.gov Identifier: NCT00236769|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : November 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Contraception Female Contraception||Drug: norelgestromin + ethinyl estradiol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1751 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17deacetyl-norgestimate and Ethinyl Estradiol.|
|Study Start Date :||November 1997|
|Actual Study Completion Date :||October 1999|
- Contraceptive efficacy is assessed with the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.
- Cycle control and compliance are assessed with diary cards containing bleeding information and dosing information.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236769
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|