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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted within the Section of Family Planning in the Department of Obstetrics and Gynecology at The University of Chicago and within the Department of Family Medicine at the University of Illinois-Chicago. From December 2007 through June 2008, 37 adolescent females were approached regarding the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All of the 23 enrolled subjects were ultimately randomized to the treatment arms (12 to LNG-IUS and 11 to CuT380A).

Reporting Groups
  Description
Paragard IUD [CuT380A] Paragard intrauterine device (IUD), Copper T 380A
Mirena IUD [LNG-IUS] Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System

Participant Flow:   Overall Study
    Paragard IUD [CuT380A]     Mirena IUD [LNG-IUS]  
STARTED     11     12  
COMPLETED     6     9  
NOT COMPLETED     5     3  
Adverse Event                 4                 1  
Lost to Follow-up                 1                 2  



  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


  More Information