NCT00777556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 18, 2012

Completed
Last Updated

October 18, 2012

Status Verified

September 1, 2012

Enrollment Period

2.2 years

First QC Date

October 21, 2008

Results QC Date

September 14, 2012

Last Update Submit

September 14, 2012

Conditions

Emergency Contraception

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions

    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.

    Day 1

  • Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions

    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.

    Week 1

Secondary Outcomes (2)

  • Participants With Treatment-Emergent Adverse Events (TEAE)

    Day 1 to week 8

  • Participants Summarized by Repeat Use of Emergency Contraception (EC)

    up to week 8

Study Arms (1)

DR-104

EXPERIMENTAL

One tablet for emergency contraception

Drug: DR-104

Interventions

DR-104DRUG

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

Also known as: Plan B® 1.5, Plan B One-Step®, levonorgestrel
DR-104

Eligibility Criteria

Age11 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Duramed Research Investigational Site

San Francisco, California, 94110, United States

Location

Duramed Research Investigational Site

Atlanta, Georgia, 30303, United States

Location

Duramed Research Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

Duramed Research Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Teva Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Director, Clinical Research
Organization
Teva Branded Pharmaceutical Products, R&D Inc.
ustevatrials@tevapharm.com
215-591-3000

Study Officials

  • Duramed Research Protocol Chair

    Duramed Research, Inc

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 22, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 18, 2012

Results First Posted

October 18, 2012

Record last verified: 2012-09

Locations

US(5)