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
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Sponsor:
University of Chicago
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Melissa Gilliam, University of Chicago
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Study Type | Interventional |
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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) |
Enrollment | 23 |
Participant Flow
Recruitment Details | 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 | All of the 23 enrolled subjects were ultimately randomized to the treatment arms (12 to LNG-IUS and 11 to CuT380A). |
Arm/Group Title | Paragard IUD [CuT380A] | Mirena IUD [LNG-IUS] |
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Paragard intrauterine device (IUD), Copper T 380A | Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System |
Period Title: Overall Study | ||
Started | 11 | 12 |
Completed | 6 | 9 |
Not Completed | 5 | 3 |
Reason Not Completed | ||
Adverse Event | 4 | 1 |
Lost to Follow-up | 1 | 2 |
Baseline Characteristics
Arm/Group Title | Paragard IUD [CuT380A] | Mirena IUD [LNG-IUS] | Total | |
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Paragard intrauterine device (IUD), Copper T 380A | Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System | Total of all reporting groups | |
Overall Number of Baseline Participants | 11 | 12 | 23 | |
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[Not Specified]
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Age Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 11 participants | 12 participants | 23 participants | |
17
(15 to 18)
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16.5
(14 to 18)
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16.5
(14 to 18)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | 12 participants | 23 participants | |
Female |
11 100.0%
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12 100.0%
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23 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | 12 participants | 23 participants | |
Hispanic or Latino |
1 9.1%
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1 8.3%
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2 8.7%
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Not Hispanic or Latino |
10 90.9%
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11 91.7%
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21 91.3%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | 12 participants | 23 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
1 9.1%
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0 0.0%
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1 4.3%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
6 54.5%
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9 75.0%
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15 65.2%
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White |
4 36.4%
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2 16.7%
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6 26.1%
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More than one race |
0 0.0%
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1 8.3%
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1 4.3%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Education
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 11 participants | 12 participants | 23 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] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 11 participants | 12 participants | 23 participants |
Parous | 7 | 4 | 11 | |
Nulliparous | 4 | 8 | 12 | |
[1]
Measure Description: A parous female participant has given birth one or more times. A female is nulliparous if she has never given birth.
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Previous STI
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 11 participants | 12 participants | 23 participants |
Yes | 4 | 2 | 6 | |
No | 7 | 10 | 17 | |
[1]
Measure Description: 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.
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Presence of STI at screening visit
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 11 participants | 12 participants | 23 participants |
Yes | 1 | 3 | 4 | |
No | 10 | 9 | 19 | |
[1]
Measure Description: 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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
EMail: | swatson@health.bsd.uchicago.edu |
Responsible Party: | Melissa Gilliam, University of Chicago |
ClinicalTrials.gov Identifier: | NCT00653159 |
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 |