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

University of Chicago23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Contraception

Interventions

Levonorgestrel-releasing intrauterine device (LNG-IUS)DEVICE

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

Copper T380A intrauterine device (CuT380A)DEVICE

Teens are randomly assigned to Copper T380 after the screening visit

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Illinois at Chicago

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Retention Rate

Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)

Time frame: 6 months

Secondary Outcomes

Heavy Bleeding Rates

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

Time frame: 6 months

Pregnancy Rates

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

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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