At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)
In Brief
A Phase 3 clinical trial evaluating Norethindrone Acetate/Ethinyl Estradiol 24 Days and Norethindrone Acetate /Ethinyl Estradiol 21 Days for Prevention of Pregnancy. Completed, enrolled 938 participants across 34 sites.
Detailed Summary
This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.
Study Details
Timeline
Interventions
One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets