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Emergency Contraception Actual Use Study

NCT00777556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2012-10-18

Study results available
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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.

Conditions

  • Emergency Contraception

Interventions

DRUG

DR-104

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

Sponsors & Collaborators

  • Duramed Research

    lead INDUSTRY

Principal Investigators

  • Duramed Research Protocol Chair · Duramed Research, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00777556 on ClinicalTrials.gov