Phase 3
N=343
Emergency Contraception Actual Use Study
Emergency Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00777556 ↗Enrolled (actual)
343
Serious AEs
0.3%
Results posted
Oct 2012
Primary outcome: Primary: Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions — 90.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DR-104 (Drug)
- Age
- Pediatric · 11+ yrs
- Sex
- Female
- Sponsor
- Duramed Research
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions |
90.1 | — |
| PRIMARY Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions |
88.6 | — |
| SECONDARY Participants With Treatment-Emergent Adverse Events (TEAE) |
43; 0; 1 | — |
| SECONDARY Participants Summarized by Repeat Use of Emergency Contraception (EC) |
251; 38; 16; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Female and 11-16 years of age, inclusive
- Subject must be requesting emergency contraception for her own use (not for use by another person) and for current (not future) use
- Subject can read and understand English, according to her own judgment
- Others as dictated by FDA-approved protocol
Data sourced from ClinicalTrials.gov (NCT00777556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.