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Emergency Contraception Actual Use Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00777556
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : October 18, 2012
Last Update Posted : October 18, 2012
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc. ( Duramed Research )

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.

Condition or disease Intervention/treatment Phase
Emergency Contraception Drug: DR-104 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents
Study Start Date : October 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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:
  • Plan B® 1.5
  • Plan B One-Step®
  • levonorgestrel

Primary Outcome Measures :
  1. Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions [ Time Frame: Day 1 ]
    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.

  2. Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions [ Time Frame: Week 1 ]
    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.

Secondary Outcome Measures :
  1. Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Day 1 to week 8 ]
    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.

  2. Participants Summarized by Repeat Use of Emergency Contraception (EC) [ Time Frame: up to week 8 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777556

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United States, California
Duramed Research Investigational Site
San Francisco, California, United States, 94110
United States, Georgia
Duramed Research Investigational Site
Atlanta, Georgia, United States, 30303
United States, Minnesota
Duramed Research Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, Pennsylvania
Duramed Research Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Teva Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Duramed Research
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Study Chair: Duramed Research Protocol Chair Duramed Research, Inc
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Responsible Party: Duramed Research
ClinicalTrials.gov Identifier: NCT00777556    
Other Study ID Numbers: DR-LEV-302
First Posted: October 22, 2008    Key Record Dates
Results First Posted: October 18, 2012
Last Update Posted: October 18, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral