Emergency Contraception Actual Use Study

Emergency Contraception Clinical Trial

Official title:

Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777556
• Other study ID #: DR-LEV-302
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2008
• Last updated: September 14, 2012
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 16 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Emergency Contraception

Intervention

Drug:
• DR-104
One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.

Locations

Country	Name	City	State
United States	Duramed Research Investigational Site	Atlanta	Georgia
United States	Duramed Research Investigational Site	Minneapolis	Minnesota
United States	Duramed Research Investigational Site	Philadelphia	Pennsylvania
United States	Teva Investigational Site	Pittsburgh	Pennsylvania
United States	Duramed Research Investigational Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Participants With Treatment-Emergent Adverse Events (TEAE)	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.	Day 1 to week 8	Yes
Secondary	Participants Summarized by Repeat Use of Emergency Contraception (EC)	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.	up to week 8	No