Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial (MINT)
This study has been completed.
Sponsor:
University of Chicago
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
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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
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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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:
Results Point of Contact:
| 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
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 |
| Study First Received: | April 1, 2008 |
| Results First Received: | September 18, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | United States: Institutional Review Board |