Emergency Contraception Actual Use Study

• ClinicalTrials.gov Identifier: NCT00777556
• Recruitment Status: Completed
• First Posted: October 22, 2008
• Results First Posted: October 18, 2012
• Last Update Posted: October 18, 2012
• Sponsor: Duramed Research
• Information provided by (Responsible Party): Teva Pharmaceutical Industries ( Duramed Research )

Tracking Information

• First Submitted Date: October 21, 2008
• First Posted Date: October 22, 2008
• Results First Submitted Date: September 14, 2012
• Results First Posted Date: October 18, 2012
• Last Update Posted Date: October 18, 2012
• Study Start Date: October 2008
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 14, 2012)

• 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.
• 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.

Original Primary Outcome Measures (submitted: October 21, 2008)

• Percentage of subjects who appropriately self-select DR-104 when dispensed under simulated OTC condition [ Time Frame: Duration of study ]
• Proportion of subjects who correctly use DR-104 when dispensed under simulated OTC conditions [ Time Frame: Duration of study ]

• Change History: Complete list of historical versions of study NCT00777556 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: September 14, 2012)

• 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.
• 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.

Original Secondary Outcome Measures (submitted: October 21, 2008)

• Incidence of adverse events [ Time Frame: Duration of study ]
• Repeat use of emergency contraception (a product other than the study product) [ Time Frame: Duration of study ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Emergency Contraception Actual Use Study
• Official Title: Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents
• 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Emergency Contraception

Intervention

Drug: DR-104

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

Study Arms

Experimental: DR-104

One tablet for emergency contraception

Intervention: Drug: DR-104

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 14, 2012): 343
• Original Estimated Enrollment (submitted: October 21, 2008): 300
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 11 Years to 16 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00777556
• Other Study ID Numbers: DR-LEV-302
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
• Study Sponsor: Duramed Research
• Collaborators: Not Provided

Investigators

• Study Chair: Duramed Research Protocol Chair; Duramed Research, Inc

• PRS Account: Teva Pharmaceutical Industries
• Verification Date: September 2012