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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
Sponsor:
Collaborator:
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
  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

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 
Overall Participants Analyzed 
[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 
[1] A parous female participant has given birth one or more times. A female is nulliparous if she has never given birth.
Previous STI [1] 
[Units: Participants]
 		     
Yes   4   2   6 
No   7   10   17 
[1] 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.
Presence of STI at screening visit [1] 
[Units: Participants]
 		     
Yes   1   3   4 
No   10   9   19 
[1] 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

1.  Primary:   Retention Rate   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Heavy Bleeding Rates   [ Time Frame: 6 months ]
  Show Outcome Measure 2

3.  Secondary:   Pregnancy Rates   [ Time Frame: 6 months ]
  Show Outcome Measure 3

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

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


  Serious Adverse Events

Time Frame No text entered.
Additional Description 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

Serious Adverse Events
    Paragard IUD [CuT380A]   Mirena IUD [LNG-IUS]
Total, Serious Adverse Events     
# participants affected / at risk   0/11 (0.00%)   0/12 (0.00%) 




  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
No text entered.


  More Information

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


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



Responsible Party: Melissa Gilliam, University of Chicago
ClinicalTrials.gov Identifier: NCT00653159     History of Changes
Other Study ID Numbers: 15498A
First Submitted: April 1, 2008
First Posted: April 4, 2008
Results First Submitted: September 18, 2012
Results First Posted: October 18, 2012
Last Update Posted: October 19, 2012