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

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ClinicalTrials.gov Identifier: NCT00653159
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : October 18, 2012
Last Update Posted : October 19, 2012
University of Illinois at Chicago
Information provided by (Responsible Party):
Melissa Gilliam, University of Chicago

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Contraception
Interventions: Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)
Device: Copper T380A intrauterine device (CuT380A)

  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
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 
Adverse Event                4                1 
Lost to Follow-up                1                2 

  Baseline Characteristics

  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