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

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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.
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]

Age
[Units: Years]
Median (Full Range)

17
(15 to 18)

16.5
(14 to 18)

Gender
[Units: Participants]

Female

Male

Ethnicity (NIH/OMB)
[Units: Participants]

Hispanic or Latino

Not Hispanic or Latino

Unknown or Not Reported

Race (NIH/OMB)
[Units: Participants]

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or Not Reported

Education
[Units: Participants]

8th grade or less

Current high school student

High school diploma/GED

Some college/current college student

Parous ^[1]
[Units: Participants]

Parous

Nulliparous

^[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

^[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]	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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Measure Type	Secondary
Measure Title	Heavy Bleeding Rates
Measure Description	Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
Time Frame	6 months

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.
All study participants were included in the analysis.

Reporting Groups

	Description
Paragard IUD [CuT380A]	Paragard intrauterine device (IUD), Copper T 380A
Mirena IUD [LNG-IUS]	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System

Measured Values

	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Participants Analyzed [Units: Participants]	11	12
Heavy Bleeding Rates [Units: Percentage of randomized subjects]	55	33

Statistical Analysis 1 for Heavy Bleeding Rates

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Fisher Exact
P Value ^[4]	0.4136

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	Two-sided test
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

3. Secondary:

Pregnancy Rates [ Time Frame: 6 months ]

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4. Secondary:

Expulsion Rates [ Time Frame: 6 months ]

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Measure Type	Secondary
Measure Title	Expulsion Rates
Measure Description	Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.
Time Frame	6 months

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.
All study participants were included in the analysis.

Reporting Groups

	Description
Paragard IUD [CuT380A]	Paragard intrauterine device (IUD), Copper T 380A
Mirena IUD [LNG-IUS]	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System

Measured Values

	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Participants Analyzed [Units: Participants]	11	12
Expulsion Rates [Units: Percentage of randomized subjects]	18	0

Statistical Analysis 1 for Expulsion Rates

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Fisher Exact
P Value ^[4]	0.2174

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	Two-sided test
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

5. Secondary:

Device Satisfaction Rates [ Time Frame: 6 months ]

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Serious Adverse Events

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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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