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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)
Enrollment 23
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]
Hide 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
Arm/Group Title Paragard IUD [CuT380A] Mirena IUD [LNG-IUS] Total
Hide 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
Hide 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.
1.Primary Outcome
Title Retention Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants were included in the analysis.
Arm/Group Title Paragard IUD [CuT380A] Mirena IUD [LNG-IUS]
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants were included in the analysis.
Arm/Group Title Paragard IUD [CuT380A] Mirena IUD [LNG-IUS]
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Proportion of subjects who became pregnant within 6 months of IUD insertion
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants were included in the analysis.
Arm/Group Title Paragard IUD [CuT380A] Mirena IUD [LNG-IUS]
Hide 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
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants were included in the analysis.
Arm/Group Title Paragard IUD [CuT380A] Mirena IUD [LNG-IUS]
Hide 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
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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]
Hide 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
Show Statistical Analysis 1 Hide 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
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paragard IUD [CuT380A] Mirena IUD [LNG-IUS]
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide 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%) 
Show Other (Not Including Serious) Adverse Events Hide 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.
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
Responsible Party: Melissa Gilliam, University of Chicago
ClinicalTrials.gov Identifier: NCT00653159     History of Changes
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