Emergency Contraception Actual Use Study

Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Emergency Contraception
• Intervention / Treatment: Drug: DR-104

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.

• Study Type: Interventional
• Enrollment (Actual): 343
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Duramed Research Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Duramed Research Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Duramed Research Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Duramed Research Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Teva Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DR-104; One tablet for emergency contraception	Drug: DR-104; One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.; Other Names: levonorgestrel; Plan B® 1.5; Plan B One-Step®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions	The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.	Day 1
Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions	The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Treatment-Emergent Adverse Events (TEAE)	Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug.	Day 1 to week 8
Participants Summarized by Repeat Use of Emergency Contraception (EC)	As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses.	up to week 8

Collaborators and Investigators

• Sponsor: Duramed Research

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (ESTIMATE): October 22, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2012
• Last Update Submitted That Met QC Criteria: September 14, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: DR-LEV-302