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Completed

NCT Number: NCT00653159

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

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.

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Key information

Conditions

Age range

14 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levonorgestrel-releasing intrauterine device (LNG-IUS)

Device

Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.

Other names: Mirena IUD

Copper T380A intrauterine device (CuT380A)

Device

Teens are randomly assigned to Copper T380 after the screening visit

Other names: Paraguard IUD

Primary outcomes

  1. 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)

Secondary outcomes

  1. Heavy Bleeding Rates

    Time frame: 6 months

    Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.

  2. Pregnancy Rates

    Time frame: 6 months

    Proportion of subjects who became pregnant within 6 months of IUD insertion

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • University of Illinois at Chicago

Registry information

Official study 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

Acronym: MINT

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 4, 2008
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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