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

• Heavy Bleeding Rates [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
• Pregnancy Rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Proportion of subjects who became pregnant within 6 months of IUD insertion
• Expulsion Rates [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: No ]
  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.

• Bleeding patterns and rates of dysmenorrhea among teens randomized to the LNG-IUS or Copper T 380A. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
• Rates of expulsion and pregnancy for teens randomized to the LNG-IUS or Copper T 380A. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
• Quality of life among teens randomized to the LNG-IUS or Copper T 380A [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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.

• 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
• Device: Copper T380A intrauterine device (CuT380A)
  Teens are randomly assigned to Copper T380 after the screening visit
  Other Name: Paraguard IUD

• 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.
  Intervention: Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)
• 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.
  Intervention: Device: Copper T380A intrauterine device (CuT380A)

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