Clinical trial NCT00777556: Emergency Contraception Actual Use Study
Official title: Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Emergency Contraception
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 343
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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® 1.5), 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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions
timeFrame: Day 1
measure: Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions
timeFrame: Week 1
Secondary outcomes:
measure: Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: Day 1 to week 8
measure: Participants Summarized by Repeat Use of Emergency Contraception (EC)
timeFrame: up to week 8
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Duramed Research Investigational Site
state: California
city: Atlanta
country: United States
facility: Duramed Research Investigational Site
state: Georgia
city: Minneapolis
country: United States
facility: Duramed Research Investigational Site
state: Minnesota
city: Philadelphia
country: United States
facility: Duramed Research Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site
state: Pennsylvania
Study officials:
affiliation: Duramed Research, Inc
name: Duramed Research Protocol Chair
role: STUDY_CHAIR
References: