A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.
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|ClinicalTrials.gov Identifier: NCT00236795|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Contraception Female Contraception||Drug: norelgestromin + ethinyl estradiol; triphasil.||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1494 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study to Evaluate the Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17-deacetylnorgestimate and Ethinyl Estradiol With the Oral Contraceptive Triphasil.|
|Study Start Date :||January 1997|
|Actual Study Completion Date :||March 1999|
- Contraceptive efficacy of the 2 treatments was estimated by determination of pregnancy rates, using the Pearl Index and life table analysis (cumulative probability of pregnancy). Safety was evaluated throughout the study.
- Cycle control and compliance were assessed with diary cards containing bleeding 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): NCT00236795
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|