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Completed

NCT Number: NCT00777556

Emergency Contraception Actual Use Study

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.

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Key information

Conditions

Emergency Contraception

Age range

11 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Research Investigational Site, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DR-104

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 22, 2008
Registry last updated
Oct 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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