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


  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 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.



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 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.



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 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.



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 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 ]

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 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.




  Serious Adverse Events


  Other Adverse Events


  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