An Open Label Study to Evaluate Cycle Control With Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) and Yaz (Drospirenone/Ethinyl Estradiol) in Healthy Sexually Active Females
Abstract
The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.
Conditions: Contraception.
Primary outcome: Number of Days of Unscheduled Blood Loss - Cycle 1; Number of Days of Unscheduled Blood Loss - Cycle 2; Number of Days of Unscheduled Blood Loss - Cycle 3; Overall Number of Days of Unscheduled Blood Loss; Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes; Number of Days of Scheduled Blood Loss - Cycle 1; Number of Days of Scheduled Blood Loss - Cycle 2; Number of Days of Scheduled Blood Loss - Cycle 3; Overall Number of Days of Scheduled Blood Loss; Number of Days of Total Blood Loss - Cycle 1; Number of Days of Total Blood Loss - Cycle 2; Number of Days of Total Blood Loss - Cycle 3; Overall Number of Days of Total Blood Loss; Number of Participants With Unscheduled Bleeding Cycle 1; Number of Participants With Unscheduled Bleeding Cycle 2; Number of Participants With Unscheduled Bleeding Cycle 3; Number of Participants With Breakthrough Bleeding/Spotting Cycle 1; Number of Participants With Breakthrough Bleeding/Spotting Cycle 2; Number of Participants With Breakthrough Bleeding/Spotting Cycle 3.
Enrollment: 355 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 355 participants or records.
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