Status:
COMPLETED
Emergency Contraception Actual Use Study
Lead Sponsor:
Duramed Research
Conditions:
Emergency Contraception
Eligibility:
FEMALE
11-16 years
Phase:
PHASE3
Brief 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....
Detailed Description
To simulate an over-the-counter (OTC) setting, each potential subject was expected to read the label text on the outside of the study package and determine whether and how to use the study product wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT00777556
Start Date
October 1 2008
End Date
December 1 2010
Last Update
October 18 2012
Active Locations (5)
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1
Duramed Research Investigational Site
San Francisco, California, United States, 94110
2
Duramed Research Investigational Site
Atlanta, Georgia, United States, 30303
3
Duramed Research Investigational Site
Minneapolis, Minnesota, United States, 55404
4
Duramed Research Investigational Site
Philadelphia, Pennsylvania, United States, 19104