Text Size

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

This study has been completed.
Sponsor:
Collaborator:
University of Illinois
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
History of Changes
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
  Hide 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
  Hide Baseline Characteristics

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 ]
  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
  Show Serious Adverse Events


  Other Adverse Events
  Show 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