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Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial

This study has been completed.
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Melissa Gilliam, University of Chicago
ClinicalTrials.gov Identifier:
NCT00653159
First received: April 1, 2008
Last updated: October 17, 2012
Last verified: October 2012
Results First Received: September 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Contraception
Interventions: Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)
Device: Copper T380A intrauterine device (CuT380A)

  Participant Flow


  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Retention Rate   [ Time Frame: 6 months ]

2.  Secondary:   Heavy Bleeding Rates   [ Time Frame: 6 months ]

3.  Secondary:   Pregnancy Rates   [ Time Frame: 6 months ]

4.  Secondary:   Expulsion Rates   [ Time Frame: 6 months ]

5.  Secondary:   Device Satisfaction Rates   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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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