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Emergency Contraception Actual Use Study

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Emergency Contraception

Intervention: DR-104 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Duramed Research Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc

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.

Clinical Details

Official title: Plan B 1.5 Emergency Contraception Actual Use Study in Adolescents

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions

Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions

Secondary outcome:

Participants With Treatment-Emergent Adverse Events (TEAE)

Participants Summarized by Repeat Use of Emergency Contraception (EC)

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.

Eligibility

Minimum age: 11 Years. Maximum age: 16 Years. Gender(s): Female.

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

Locations and Contacts

Duramed Research Investigational Site, San Francisco, California 94110, United States

Duramed Research Investigational Site, Atlanta, Georgia 30303, United States

Duramed Research Investigational Site, Minneapolis, Minnesota 55404, United States

Duramed Research Investigational Site, Philadelphia, Pennsylvania 19104, United States

Teva Investigational Site, Pittsburgh, Pennsylvania 15213, United States

Additional Information

Starting date: October 2008
Last updated: September 14, 2012

Page last updated: August 23, 2015

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