At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,700 enrolled
Drug / intervention
Norethindrone/ethinyl estradioldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.
In Brief
A Phase 3 clinical trial evaluating Norethindrone/ethinyl estradiol for Contraception. Completed, enrolled 1,700 participants across 63 sites.
Detailed Summary
This is a non-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; and to assess the safety and tolerability of the product.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJun 2007
Primary CompletionJan 2009
Study CompletionFeb 2009
TodayJul 2026
First PostedMay 24, 2007
Enrollment StartJun 1, 2007
Primary CompletionJan 1, 2009
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.1 years ago
Interventions
Norethindrone/ethinyl estradioldrug
1 tablet per day