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
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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
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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.
No text entered.

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

Baseline Measures
    Paragard IUD [CuT380A]     Mirena IUD [LNG-IUS]     Total  
Number of Participants  
[units: participants]
  11     12     23  
Age  
[units: years]
Median ( Full Range )
  17  
  ( 15 to 18 )  
  16.5  
  ( 14 to 18 )  
  16.5  
  ( 14 to 18 )  
Gender  
[units: participants]
     
Female     11     12     23  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     1     2  
Not Hispanic or Latino     10     11     21  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     9     15  
White     4     2     6  
More than one race     0     1     1  
Unknown or Not Reported     0     0     0  
Education  
[units: participants]
     
8th grade or less     0     1     1  
Current high school student     8     10     18  
High school diploma/GED     2     0     2  
Some college/current college student     1     1     2  
Parous [1]
[units: participants]
     
Parous     7     4     11  
Nulliparous     4     8     12  
Previous STI [2]
[units: participants]
     
Yes     4     2     6  
No     7     10     17  
Presence of STI at screening visit [3]
[units: participants]
     
Yes     1     3     4  
No     10     9     19  
[1] A parous female participant has given birth one or more times. A female is nulliparous if she has never given birth.
[2] Number of participants who have previously tested positive for one or more of the following sexually transmitted infections (STI) during the screening visit: chlamydia, gonorrhea, trichomonas, and vaginal warts.
[3] Number of participants who tested positive for one or more of the following sexually transmitted infections (STI) during the screening visit: chlamydia, gonorrhea, trichomonas, and vaginal warts.



  Outcome Measures
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1.  Primary:   Retention Rate   [ Time Frame: 6 months ]
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Measure Type Primary
Measure Title Retention Rate
Measure Description Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
Time Frame 6 months  
Safety Issue No  

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
  Description
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]  
Number of Participants Analyzed  
[units: participants]
  11     12  
Retention Rate  
[units: percentage of randomized subjects]
  55     75  


Statistical Analysis 1 for Retention Rate
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.4003
[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 completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Two-sided test
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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