At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,683 enrolled
Drug / intervention
Norethindrone acetate/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.
Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol
In Brief
A Phase 3 clinical trial evaluating Norethindrone acetate/ethinyl estradiol for Contraception. Completed, enrolled 1,683 participants across 66 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 PostedOct 2006
Enrollment StartNov 2006
Primary CompletionAug 2008
Study CompletionSep 2008
TodayJul 2026
First PostedOct 24, 2006
Enrollment StartNov 1, 2006
Primary CompletionAug 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.7 years ago
Interventions
Norethindrone acetate/ethinyl estradioldrug
one tablet per day