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

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Device: Levonorgestrel-releasing intrauterine device (LNG-IUS); Device: Copper T380A intrauterine device (CuT380A)

Study type: Interventional

Funder types: Other

Identifiers

NCT00653159

15498A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: Female

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

23 participants in 2 patient groups

Mirena IUD [LNG-IUS]

Active Comparator group

Description:

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.

Treatment:

Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)

Paragard IUD [Copper T380A]

Active Comparator group

Description:

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.

Treatment:

Device: Copper T380A intrauterine device (CuT380A)