Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 100 of 405 for:    LEVONORGESTREL

Emergency Contraception Actual Use Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )

Tracking Information
First Submitted Date  ICMJE October 21, 2008
First Posted Date  ICMJE October 22, 2008
Results First Submitted Date  ICMJE September 14, 2012
Results First Posted Date  ICMJE October 18, 2012
Last Update Posted Date October 18, 2012
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE Emergency Contraception Actual Use Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Emergency Contraception
Intervention  ICMJE 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  ICMJE Experimental: DR-104
One tablet for emergency contraception
Intervention: Drug: DR-104
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2012)
343
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
300
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 11 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777556
Other Study ID Numbers  ICMJE DR-LEV-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Duramed Research )
Study Sponsor  ICMJE Duramed Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Duramed Research Protocol Chair Duramed Research, Inc
PRS Account Teva Pharmaceutical Industries
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP