NCT00777556

Emergency Contraception Actual Use Study

Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 11 Years – 16 Years
• Healthy volunteers: Accepted

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.

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 without provider direction or assistance. The study product, Plan B® 1.5, was to be dispensed only to those subjects who appropriately self-selected and indicated that they wanted to participate in the study and receive study product. Subjects could also appropriately self-select not to use the study product. Follow-up contact was to be conducted at approximately one, four, and eight weeks following the date the subject was dispensed study product. At these contacts, subjects answered questions regarding product use, health problems since last contact, and pregnancy status. Subjects were not to be permitted to enroll more than once in this Actual Use Study, however to assess repeat use of emergency contraceptives (EC) (use in addition to the study product) subjects were also queried at the one-, four-, and eight-week follow-up contacts regarding use of additional EC.

Conditions

• Emergency Contraception

Interventions

Type	Name	Description
DRUG	DR-104	One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-10-22
• Last updated: 2012-10-18
• Results posted: 2012-10-18

Locations

5 sites across 1 country: United States