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Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception

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: NCT00669396
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : August 6, 2009
Last Update Posted : December 22, 2014
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Pregnancy
Interventions: Drug: Copper T380 IUD
Drug: levonorgestrel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Copper T380 IUD IUD
Levonorgestrel Oral levonorgestrel

Participant Flow:   Overall Study
    Copper T380 IUD   Levonorgestrel
STARTED   23   34 
COMPLETED   13   22 
NOT COMPLETED   10   12 
Lost to Follow-up                10                12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Copper T380 IUD IUD
Levonorgestrel Oral levonorgestrel
Total Total of all reporting groups

Baseline Measures
   Copper T380 IUD   Levonorgestrel   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   34   57 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   23   34   57 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 24.7  (6.7)   23.0  (4.7)   23.7  (5.6) 
Gender 
[Units: Participants]
     
Female   23   34   57 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   23   34   57 


  Outcome Measures

1.  Primary:   Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception   [ Time Frame: 6 months ]

2.  Secondary:   Pregnancy   [ Time Frame: 6 months ]

3.  Secondary:   Infection   [ Time Frame: 6 months ]

4.  Secondary:   IUD Expulsion, Removal, or Perforation   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Turok, MD
Organization: University of Utah
phone: 801-581-7647
e-mail: david.turok@hsc.utah.edu



Responsible Party: David Turok, University of Utah
ClinicalTrials.gov Identifier: NCT00669396     History of Changes
Other Study ID Numbers: 23111
IUDvsPlanBforEC
First Submitted: April 25, 2008
First Posted: April 30, 2008
Results First Submitted: June 18, 2009
Results First Posted: August 6, 2009
Last Update Posted: December 22, 2014