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

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. 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 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Heavy Bleeding Rates
Measure Description Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
Time Frame 6 months  

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.
All study participants were included in the analysis.

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

Measured Values
   Paragard IUD [CuT380A]   Mirena IUD [LNG-IUS] 
Participants Analyzed   11   12 
Heavy Bleeding Rates 
[Units: Percentage of randomized subjects]
 55   33 

Statistical Analysis 1 for Heavy Bleeding Rates
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Fisher Exact
P Value [4] 0.4136
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
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[3] Other relevant method information, such as adjustments or degrees of freedom:
  Two-sided test
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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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

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