Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial

Study Overview
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Brief Summary
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This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Copper T 380A.

Detailed Description
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Teenagers have the highest percentage of unintended pregnancies, and often struggle to comply with daily methods of contraception. The intrauterine device (IUD) provides safe, long-term protection and rates highly for patient satisfaction. It also does not require repeat prescriptions or clinic visits, making it a potentially attractive method among teens. However, in adolescent populations, there is both a lack of information about the IUD, as well as few studies that have examined the use of these devices. This study will examine whether a larger scale study on this topic is feasible. IT will address the feasibility of recruiting, consenting, screening, enrolling, randomizing, and retaining adolescents randomized to the LNG-IUS or Copper T 380a.

Official Title
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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

Conditions
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Contraception

Intervention / Treatment
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* Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)
* Device: Copper T380A intrauterine device (CuT380A)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mirena IUD [LNG-IUS]<br>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. | Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)<br>* Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.<br>* Other names: Mirena IUD;|
| Active Comparator: Paragard IUD [Copper T380A]<br>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. | Device: Copper T380A intrauterine device (CuT380A)<br>* Teens are randomly assigned to Copper T380 after the screening visit<br>* Other names: Paraguard IUD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate | Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heavy Bleeding Rates | Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A. | 6 months | 
| Pregnancy Rates | Proportion of subjects who became pregnant within 6 months of IUD insertion | 6 months | 
| Expulsion Rates | 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. | 6 months | 
| Device Satisfaction Rates | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine device, contraception, unplanned pregnancy