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
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Condition or disease | Intervention/treatment | Phase |
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Contraception | Device: Levonorgestrel-releasing intrauterine device (LNG-IUS) Device: Copper T380A intrauterine device (CuT380A) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Intrauterine Contraception for Adolescents Aged 14 to 18: A Multi-center Randomized Controlled Feasibility Trial of Levonorgestrel-releasing Intrauterine System Compared to the Copper T 380A |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
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Active Comparator: Mirena IUD [LNG-IUS]
Participants in this arm had a Levonorgestrel-releasing intrauterine device (LNG-IUS), also known as the Mirena IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.
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Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)
Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.
Other Name: Mirena IUD |
Active Comparator: Paragard IUD [Copper T380A]
Participants in this arm had a Copper T380A intrauterine device (CuT380A), also known as the Paragard IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.
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Device: Copper T380A intrauterine device (CuT380A)
Teens are randomly assigned to Copper T380 after the screening visit
Other Name: Paraguard IUD |
- Retention Rate [ Time Frame: 6 months ]Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
- Heavy Bleeding Rates [ Time Frame: 6 months ]Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
- Pregnancy Rates [ Time Frame: 6 months ]Proportion of subjects who became pregnant within 6 months of IUD insertion
- Expulsion Rates [ Time Frame: 6 months ]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.
- Device Satisfaction Rates [ Time Frame: 6 months ]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.

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Ages Eligible for Study: | 14 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy, sexually active females age 14 to 18 who:
- Are interested in long term, reversible contraception
- Have regular menstrual cycles (21-35 days)
- Are not planning a pregnancy within the next 6 months
Exclusion Criteria:
Sexually active females age over the age of 18 or who:
- Are not interested in long term, reversible contraception
- Do not have regular menstrual cycles (21-35 days)
- Are planning a pregnancy within the next 6 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653159
United States, Illinois | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Melissa Gilliam, MD | The University of Chicago Medicine |
Responsible Party: | Melissa Gilliam, Professor of Medicine, University of Chicago |
ClinicalTrials.gov Identifier: | NCT00653159 |
Other Study ID Numbers: |
15498A |
First Posted: | April 4, 2008 Key Record Dates |
Results First Posted: | October 18, 2012 |
Last Update Posted: | October 19, 2012 |
Last Verified: | October 2012 |
Intrauterine device, contraception, unplanned pregnancy |
Copper Levonorgestrel Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
Contraceptives, Oral, Synthetic Contraceptives, Oral Trace Elements Micronutrients Nutrients Growth Substances |