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

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

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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

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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.
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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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1. Primary:

Retention Rate [ Time Frame: 6 months ]

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2. Secondary:

Heavy Bleeding Rates [ Time Frame: 6 months ]

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3. Secondary:

Pregnancy Rates [ Time Frame: 6 months ]

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4. Secondary:

Expulsion Rates [ Time Frame: 6 months ]

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5. Secondary:

Device Satisfaction Rates [ Time Frame: 6 months ]

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Serious Adverse Events

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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

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Limitations and Caveats

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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
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More Information

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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

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

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