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

Hide All Outcome Measures

1. Primary:

Retention Rate [ Time Frame: 6 months ]

Measure Type	Primary
Measure Title	Retention Rate
Measure Description	Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
Time Frame	6 months
Safety Issue	No

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]
Number of Participants Analyzed [units: participants]	11	12
Retention Rate [units: percentage of randomized subjects]	55	75

Statistical Analysis 1 for Retention Rate

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.4003

[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 completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Two-sided test
[3]	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.

2. Secondary:

Heavy Bleeding Rates [ Time Frame: 6 months ]

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
Safety Issue	Yes

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]
Number of 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
Method ^[2]	Fisher Exact
P Value ^[3]	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]	Other relevant information, such as adjustments or degrees of freedom:
	Two-sided test
[3]	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 ]

Measure Type	Secondary
Measure Title	Pregnancy Rates
Measure Description	Proportion of subjects who became pregnant within 6 months of IUD insertion
Time Frame	6 months
Safety Issue	No

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]
Number of Participants Analyzed [units: participants]	11	12
Pregnancy Rates [units: percentage of randomized subjects]	9	0

Statistical Analysis 1 for Pregnancy Rates

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.4783

[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 became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy rates are similar for both IUD types.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Two-sided test
[3]	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.

4. Secondary:

Expulsion Rates [ Time Frame: 6 months ]

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
Safety Issue	Yes

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]
Number of 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
Method ^[2]	Fisher Exact
P Value ^[3]	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]	Other relevant information, such as adjustments or degrees of freedom:
	Two-sided test
[3]	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 ]

Measure Type	Secondary
Measure Title	Device Satisfaction Rates
Measure Description	Satisfaction rate is the proportion of subjects who report being "happy" or "very happy" with their assigned intrauterine contraceptive method on the date of their 6 month study visit.
Time Frame	6 months
Safety Issue	No

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.
Only subjects who were not lost to follow-up at 6 months were included in this 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]
Number of Participants Analyzed [units: participants]	10	10
Device Satisfaction Rates [units: percentage of subjects completing study]	80	70

Statistical Analysis 1 for Device Satisfaction Rates

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	1.0000

[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 reported being satisfied ("happy" or "very happy") at the 6 month study visit. Under the null hypothesis, satisfaction rates are similar for both IUD types.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Two-sided test
[3]	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.

Serious Adverse Events

Hide Serious Adverse Events

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

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

To Top