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
  Hide Baseline Characteristics

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
  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 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Pregnancy Rates
Measure Description Proportion of subjects who became pregnant within 6 months of IUD insertion
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  
Pregnancy Rates  
[units: percentage of randomized subjects]
  9     0  


Statistical Analysis 1 for Pregnancy Rates
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.4783
[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 became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy 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.



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

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


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Sydeaka Watson, PhD
Organization: The University of Chicago Department of Health Studies, Biostatistics Laboratory
phone: 773-834-2378
e-mail: swatson@health.bsd.uchicago.edu


No publications provided


Responsible Party: Melissa Gilliam, University of Chicago
ClinicalTrials.gov Identifier: NCT00653159     History of Changes
Other Study ID Numbers: 15498A
Study First Received: April 1, 2008
Results First Received: September 18, 2012
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board