At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 343 enrolled
Drug / intervention
DR-104drug
Likely dose
DR-104 1.5 mgfrom 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.
Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents
In Brief
A Phase 3 clinical trial evaluating DR-104 for Emergency Contraception. Completed, enrolled 343 participants across 5 sites.
Detailed Summary
This is a non-comparative case series study to assess the ability of females 11-16 years of age, inclusive, who are requesting emergency contraception (EC) to use the study product, DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEmergency Contraception
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedOct 2008
Primary CompletionDec 2010
TodayJul 2026
First PostedOct 22, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.7 years ago
Interventions
DR-104drug
One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.