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Emergency Contraception Actual Use Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00777556
First received: October 21, 2008
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Emergency Contraception
Drug: DR-104
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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:
  • Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Day 1 to week 8 ] [ Designated as safety issue: Yes ]
    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.

  • Participants Summarized by Repeat Use of Emergency Contraception (EC) [ Time Frame: up to week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 343
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777556

Locations
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
Investigators
Study Chair: Duramed Research Protocol Chair Duramed Research, Inc
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00777556     History of Changes
Other Study ID Numbers: DR-LEV-302
Study First Received: October 21, 2008
Results First Received: September 14, 2012
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Levonorgestrel
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014