An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen
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|ClinicalTrials.gov Identifier: NCT00320580|
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : July 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Metrorrhagia||Drug: norelgestromin/ethinyl estradiol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||239 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Multicenter Study Comparing the Bleeding Profile of Ortho Evra (Norelgestromin/Ethinyl Estradiol) Continuous Regimen vs. Ortho Evra Cyclic Regimen|
|Study Completion Date :||March 2003|
|Drug: norelgestromin/ethinyl estradiol|
- The primary efficacy variables are the total number bleeding and/or spotting days during the 84-day reference period and the number of bleeding and/or spotting episodes during the 84-day reference period.
- Secondary efficacy variables include the number of breakthrough bleeding and/or spotting days per 28-day interval, the number of breakthrough bleeding days per 28-day interval, time to first bleeding and/or spotting, duration of menses.
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): NCT00320580
|Study Director:||McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial||McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.|