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Emergency Contraception Actual Use Study

NCT ID: NCT00777556

Last Updated: 2012-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Emergency Contraception

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DR-104

One tablet for emergency contraception

Group Type EXPERIMENTAL

DR-104

Intervention Type DRUG

One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.

Interventions

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DR-104

One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.

Intervention Type DRUG

Other Intervention Names

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Plan B® 1.5 Plan B One-Step® levonorgestrel

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duramed Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duramed Research Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc

Locations

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Duramed Research Investigational Site

San Francisco, California, United States

Site Status

Duramed Research Investigational Site

Atlanta, Georgia, United States

Site Status

Duramed Research Investigational Site

Minneapolis, Minnesota, United States

Site Status

Duramed Research Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Teva Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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DR-LEV-302

Identifier Type: -

Identifier Source: org_study_id