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
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

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  
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
  Show All Outcome Measures

1.  Primary:   Retention Rate   [ Time Frame: 6 months ]

2.  Secondary:   Heavy Bleeding Rates   [ Time Frame: 6 months ]

3.  Secondary:   Pregnancy Rates   [ Time Frame: 6 months ]

4.  Secondary:   Expulsion Rates   [ Time Frame: 6 months ]
  Hide Outcome Measure 4

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 method 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 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Paragard IUD [CuT380A]     Mirena IUD [LNG-IUS]  
Total, other (not including serious) adverse events      
# participants affected / at risk     11/11     10/12  
Blood and lymphatic system disorders      
Anemia † 1 [3]    
# participants affected / at risk     0/11 (0.00%)     1/12 (8.33%)  
Gastrointestinal disorders      
Abdominal pain † 1 [4]    
# participants affected / at risk     1/11 (9.09%)     0/12 (0.00%)  
Bloating † 1 [5]    
# participants affected / at risk     2/11 (18.18%)     2/12 (16.67%)  
Vomiting † 1 [6]    
# participants affected / at risk     0/11 (0.00%)     1/12 (8.33%)  
Nausea † 1 [7]    
# participants affected / at risk     0/11 (0.00%)     1/12 (8.33%)  
General disorders      
Fatigue † 1 [8]    
# participants affected / at risk     0/11 (0.00%)     1/12 (8.33%)  
Fever † 1 [9]    
# participants affected / at risk     2/11 (18.18%)     3/12 (25.00%)  
Leg pain † [10]    
# participants affected / at risk     0/11 (0.00%)     1/12 (8.33%)  
Infections and infestations      
Abscess/infection of Bartholin’s gland † [11]    
# participants affected / at risk     0/11 (0.00%)     1/12 (8.33%)  
Bacterial vaginosis † [12]    
# participants affected / at risk     1/11 (9.09%)     0/12 (0.00%)  
Trichomoniasis † [13]    
# participants affected / at risk     0/11 (0.00%)     1/12 (8.33%)  
Urinary tract infection † 1 [14]    
# participants affected / at risk     1/11 (9.09%)     0/12 (0.00%)  
Investigations      
Weight gain † 1 [15]    
# participants affected / at risk     1/11 (9.09%)     2/12 (16.67%)  
Nervous system disorders      
Headaches † 1 [16]    
# participants affected / at risk     1/11 (9.09%)     1/12 (8.33%)  
Psychiatric disorders      
Libido decreased † 1 [17]    
# participants affected / at risk     1/11 (9.09%)     0/12 (0.00%)  
Psychiatric disorders – Other (Mood Swings) † [18]    
# participants affected / at risk     1/11 (9.09%)     2/12 (16.67%)  
Reproductive system and breast disorders      
Breast swelling † [19]    
# participants affected / at risk     1/11 (9.09%)     2/12 (16.67%)  
Irregular menstruation † 1 [20]    
# participants affected / at risk     1/11 (9.09%)     1/12 (8.33%)  
Menorrhagia † 1 [21]    
# participants affected / at risk     5/11 (45.45%)     5/12 (41.67%)  
Menstrual pain † [22]    
# participants affected / at risk     11/11 (100.00%)     5/12 (41.67%)  
Vaginal discharge † 1 [23]    
# participants affected / at risk     0/11 (0.00%)     3/12 (25.00%)  
Vaginal inflammation † 1 [24]    
# participants affected / at risk     0/11 (0.00%)     1/12 (8.33%)  
Skin and subcutaneous tissue disorders      
Acne † [25]    
# participants affected / at risk     0/11 (0.00%)     3/12 (25.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, CTCAE (4.0)
[3] 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.
[4] A disorder characterized by a sensation of marked discomfort in the abdominal region.
[5] A disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen.
[6] A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
[7] A disorder characterized by a queasy sensation and/or the urge to vomit.
[8] A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
[9] A disorder characterized by elevation of the body's temperature above the upper limit of normal.
[10] Pain in the leg.
[11] Abscess/infection of Bartholin’s gland
[12] 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.
[13] Trichomoniasis (or “trich”) is a very common sexually transmitted disease (STD) that is caused by infection with a protozoan parasite called Trichomonas vaginalis.
[14] A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra
[15] A finding characterized by an increase in overall body weight; for pediatrics, greater than the baseline growth curve.
[16] 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
[17] A disorder characterized by a decrease in sexual desire.
[18] A mood swing is an extreme or rapid change in mood.
[19] Swelling and tenderness of the breasts
[20] A disorder characterized by irregular cycle or duration of menses
[21] A disorder characterized by abnormally heavy vaginal bleeding during menses.
[22] Pain during menses
[23] A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.
[24] A disorder characterized by inflammation involving the vagina. Symptoms may include redness, edema, marked discomfort and an increase in vaginal discharge
[25] 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
  Hide 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.


  More Information