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) ConditionsPercentage 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
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