Trial Outcomes & Findings for Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial (NCT NCT00653159)
NCT ID: NCT00653159
Last Updated: 2023-02-23
Results Overview
Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
6 months
Results posted on
2023-02-23
Participant Flow
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.
All of the 23 enrolled subjects were ultimately randomized to the treatment arms (12 to LNG-IUS and 11 to CuT380A).
Participant milestones
| Measure |
Paragard IUD [CuT380A]
Paragard intrauterine device (IUD), Copper T 380A
|
Mirena IUD [LNG-IUS]
Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Paragard IUD [CuT380A]
Paragard intrauterine device (IUD), Copper T 380A
|
Mirena IUD [LNG-IUS]
Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
Baseline characteristics by cohort
| Measure |
Paragard IUD [CuT380A]
n=11 Participants
Paragard intrauterine device (IUD), Copper T 380A
|
Mirena IUD [LNG-IUS]
n=12 Participants
Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17 years
n=99 Participants
|
16.5 years
n=107 Participants
|
16.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Education
8th grade or less
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Education
Current high school student
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Education
High school diploma/GED
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Education
Some college/current college student
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Parous
Parous
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Parous
Nulliparous
|
4 participants
n=99 Participants
|
8 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Previous STI
Yes
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Previous STI
No
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Presence of STI at screening visit
Yes
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Presence of STI at screening visit
No
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All study participants were included in the analysis.
Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
Outcome measures
| Measure |
Paragard IUD [CuT380A]
n=11 Participants
Paragard intrauterine device (IUD), Copper T 380A
|
Mirena IUD [LNG-IUS]
n=12 Participants
Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
|
|---|---|---|
|
Retention Rate
|
55 percentage of randomized subjects
|
75 percentage of randomized subjects
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All study participants were included in the analysis.
Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
Outcome measures
| Measure |
Paragard IUD [CuT380A]
n=11 Participants
Paragard intrauterine device (IUD), Copper T 380A
|
Mirena IUD [LNG-IUS]
n=12 Participants
Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
|
|---|---|---|
|
Heavy Bleeding Rates
|
55 percentage of randomized subjects
|
33 percentage of randomized subjects
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All study participants were included in the analysis.
Proportion of subjects who became pregnant within 6 months of IUD insertion
Outcome measures
| Measure |
Paragard IUD [CuT380A]
n=11 Participants
Paragard intrauterine device (IUD), Copper T 380A
|
Mirena IUD [LNG-IUS]
n=12 Participants
Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
|
|---|---|---|
|
Pregnancy Rates
|
9 percentage of randomized subjects
|
0 percentage of randomized subjects
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All study participants were included in the analysis.
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.
Outcome measures
| Measure |
Paragard IUD [CuT380A]
n=11 Participants
Paragard intrauterine device (IUD), Copper T 380A
|
Mirena IUD [LNG-IUS]
n=12 Participants
Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
|
|---|---|---|
|
Expulsion Rates
|
18 percentage of randomized subjects
|
0 percentage of randomized subjects
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only subjects who were not lost to follow-up at 6 months were included in this analysis.
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.
Outcome measures
| Measure |
Paragard IUD [CuT380A]
n=10 Participants
Paragard intrauterine device (IUD), Copper T 380A
|
Mirena IUD [LNG-IUS]
n=10 Participants
Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
|
|---|---|---|
|
Device Satisfaction Rates
|
80 percentage of subjects completing study
|
70 percentage of subjects completing study
|
Adverse Events
Paragard IUD [CuT380A]
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Mirena IUD [LNG-IUS]
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paragard IUD [CuT380A]
n=11 participants at risk
Paragard intrauterine device (IUD), Copper T 380A
|
Mirena IUD [LNG-IUS]
n=12 participants at risk
Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/11
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11
|
0.00%
0/12
|
|
Gastrointestinal disorders
Bloating
|
18.2%
2/11
|
16.7%
2/12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11
|
8.3%
1/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
|
8.3%
1/12
|
|
General disorders
Fatigue
|
0.00%
0/11
|
8.3%
1/12
|
|
General disorders
Fever
|
18.2%
2/11
|
25.0%
3/12
|
|
General disorders
Leg pain
|
0.00%
0/11
|
8.3%
1/12
|
|
Infections and infestations
Abscess/infection of Bartholin's gland
|
0.00%
0/11
|
8.3%
1/12
|
|
Infections and infestations
Bacterial vaginosis
|
9.1%
1/11
|
0.00%
0/12
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/11
|
8.3%
1/12
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11
|
0.00%
0/12
|
|
Investigations
Weight gain
|
9.1%
1/11
|
16.7%
2/12
|
|
Nervous system disorders
Headaches
|
9.1%
1/11
|
8.3%
1/12
|
|
Psychiatric disorders
Libido decreased
|
9.1%
1/11
|
0.00%
0/12
|
|
Psychiatric disorders
Psychiatric disorders - Other (Mood Swings)
|
9.1%
1/11
|
16.7%
2/12
|
|
Reproductive system and breast disorders
Breast swelling
|
9.1%
1/11
|
16.7%
2/12
|
|
Reproductive system and breast disorders
Irregular menstruation
|
9.1%
1/11
|
8.3%
1/12
|
|
Reproductive system and breast disorders
Menorrhagia
|
45.5%
5/11
|
41.7%
5/12
|
|
Reproductive system and breast disorders
Menstrual pain
|
100.0%
11/11
|
41.7%
5/12
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/11
|
25.0%
3/12
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/11
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/11
|
25.0%
3/12
|
Additional Information
Dr. Sydeaka Watson, PhD
The University of Chicago Department of Health Studies, Biostatistics Laboratory
Phone: 773-834-2378
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place