A Study of Efficacy and Safety With the Transdermal Contraceptive System.
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|