Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial (MINT)

• 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: University of Chicago
• 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)
• 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]
Arm/Group Description	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
Arm/Group Description		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
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	11 participants	12 participants	23 participants
		17; (15 to 18)	16.5; (14 to 18)	16.5; (14 to 18)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants	12 participants	23 participants
	Female	11 100.0%	12 100.0%	23 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants	12 participants	23 participants
	Hispanic or Latino	1 9.1%	1 8.3%	2 8.7%
	Not Hispanic or Latino	10 90.9%	11 91.7%	21 91.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants	12 participants	23 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	1 9.1%	0 0.0%	1 4.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	6 54.5%	9 75.0%	15 65.2%
	White	4 36.4%	2 16.7%	6 26.1%
	More than one race	0 0.0%	1 8.3%	1 4.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
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.
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.
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.

Outcome Measures

1. Primary Outcome

Title	Retention Rate
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

Outcome Measure Data

Analysis Population Description

All study participants were included in the analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description:	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Overall Number of Participants Analyzed	11	12
Measure Type: Number; Unit of Measure: percentage of randomized subjects
	55	75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4003
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	Two-sided test

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All study participants were included in the analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description:	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Overall Number of Participants Analyzed	11	12
Measure Type: Number; Unit of Measure: percentage of randomized subjects
	55	33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4136
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	Two-sided test

3. Secondary Outcome

Title	Pregnancy Rates
Description	Proportion of subjects who became pregnant within 6 months of IUD insertion
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All study participants were included in the analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description:	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Overall Number of Participants Analyzed	11	12
Measure Type: Number; Unit of Measure: percentage of randomized subjects
	9	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4783
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	Two-sided test

4. Secondary Outcome

Title	Expulsion Rates
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

Outcome Measure Data

Analysis Population Description

All study participants were included in the analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description:	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Overall Number of Participants Analyzed	11	12
Measure Type: Number; Unit of Measure: percentage of randomized subjects
	18	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2174
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	Two-sided test

5. Secondary Outcome

Title	Device Satisfaction Rates
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

Outcome Measure Data

Analysis Population Description

Only subjects who were not lost to follow-up at 6 months were included in this analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description:	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Overall Number of Participants Analyzed	10	10
Measure Type: Number; Unit of Measure: percentage of subjects completing study
	80	70

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	1.0000
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	Two-sided test

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
All-Cause Mortality
	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/11 (0.00%)	0/12 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
	Affected / at Risk (%)	Affected / at Risk (%)
Total	11/11 (100.00%)	10/12 (83.33%)
Blood and lymphatic system disorders
Anemia † 1 [1]	0/11 (0.00%)	1/12 (8.33%)
Gastrointestinal disorders
Abdominal pain † 1 [2]	1/11 (9.09%)	0/12 (0.00%)
Bloating † 1 [3]	2/11 (18.18%)	2/12 (16.67%)
Vomiting † 1 [4]	0/11 (0.00%)	1/12 (8.33%)
Nausea † 1 [5]	0/11 (0.00%)	1/12 (8.33%)
General disorders
Fatigue † 1 [6]	0/11 (0.00%)	1/12 (8.33%)
Fever † 1 [7]	2/11 (18.18%)	3/12 (25.00%)
Leg pain † [8]	0/11 (0.00%)	1/12 (8.33%)
Infections and infestations
Abscess/infection of Bartholin's gland † [9]	0/11 (0.00%)	1/12 (8.33%)
Bacterial vaginosis † [10]	1/11 (9.09%)	0/12 (0.00%)
Trichomoniasis † [11]	0/11 (0.00%)	1/12 (8.33%)
Urinary tract infection † 1 [12]	1/11 (9.09%)	0/12 (0.00%)
Investigations
Weight gain † 1 [13]	1/11 (9.09%)	2/12 (16.67%)
Nervous system disorders
Headaches † 1 [14]	1/11 (9.09%)	1/12 (8.33%)
Psychiatric disorders
Libido decreased † 1 [15]	1/11 (9.09%)	0/12 (0.00%)
Psychiatric disorders - Other (Mood Swings) † [16]	1/11 (9.09%)	2/12 (16.67%)
Reproductive system and breast disorders
Breast swelling † [17]	1/11 (9.09%)	2/12 (16.67%)
Irregular menstruation † 1 [18]	1/11 (9.09%)	1/12 (8.33%)
Menorrhagia † 1 [19]	5/11 (45.45%)	5/12 (41.67%)
Menstrual pain † [20]	11/11 (100.00%)	5/12 (41.67%)
Vaginal discharge † 1 [21]	0/11 (0.00%)	3/12 (25.00%)
Vaginal inflammation † 1 [22]	0/11 (0.00%)	1/12 (8.33%)
Skin and subcutaneous tissue disorders
Acne † [23]	0/11 (0.00%)	3/12 (25.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTCAE (4.0); [1] Disorder characterized by reduction in the amt of hemoglobin in 100 ml of blood. Signs/symptoms may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.; [2] A disorder characterized by a sensation of marked discomfort in the abdominal region.; [3] A disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen.; [4] A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.; [5] A disorder characterized by a queasy sensation and/or the urge to vomit.; [6] A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.; [7] A disorder characterized by elevation of the body's temperature above the upper limit of normal.; [8] Pain in the leg.; [9] Abscess/infection of Bartholin's gland; [10] Bacterial vaginosis is the name of a condition in women where the normal balance of bacteria in the vagina is disrupted and replaced by an overgrowth of certain bacteria. It is sometimes accompanied by discharge, odor, pain, itching, or burning.; [11] Trichomoniasis (or "trich") is a very common sexually transmitted disease (STD) that is caused by infection with a protozoan parasite called Trichomonas vaginalis.; [12] A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra; [13] A finding characterized by an increase in overall body weight; for pediatrics, greater than the baseline growth curve.; [14] A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve; [15] A disorder characterized by a decrease in sexual desire.; [16] A mood swing is an extreme or rapid change in mood.; [17] Swelling and tenderness of the breasts; [18] A disorder characterized by irregular cycle or duration of menses; [19] A disorder characterized by abnormally heavy vaginal bleeding during menses.; [20] Pain during menses; [21] A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.; [22] A disorder characterized by inflammation involving the vagina. Symptoms may include redness, edema, marked discomfort and an increase in vaginal discharge; [23] Acne is a common human skin disease, characterized by areas of skin with seborrhea (scaly red skin), comedones (blackheads and whiteheads), papules (pinheads), pustules (pimples), nodules (large papules) and possibly scarring.

Limitations and Caveats

[Not Specified]

More Information

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
• 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