Emergency Contraception Actual Use Study

Completed · Phase 3

Conditions studied: Emergency Contraception

In brief

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.

Key facts

Study ID

NCT00777556

Run by

Duramed Research

People needed

343

Starts

2008-10-01

Expected to finish

2010-12-01

Last updated by the study team

2012-10-18

Who can join

Age: 11 and older, up to 16. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• Duramed Research Investigational Site — San Francisco, California, United States
• Duramed Research Investigational Site — Atlanta, Georgia, United States
• Duramed Research Investigational Site — Minneapolis, Minnesota, United States
• Duramed Research Investigational Site — Philadelphia, Pennsylvania, United States
• Teva Investigational Site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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