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

This study has been completed.
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Melissa Gilliam, University of Chicago
ClinicalTrials.gov Identifier:
NCT00653159
First received: April 1, 2008
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Contraception
Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)
Device: Copper T380A intrauterine device (CuT380A)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Retention Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)


Secondary Outcome Measures:
  • 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.


Enrollment: 23
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Device: Copper T380A intrauterine device (CuT380A)
Teens are randomly assigned to Copper T380 after the screening visit
Other Name: Paraguard IUD

Detailed 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.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653159

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Chicago
University of Illinois at Chicago
Investigators
Principal Investigator: Melissa Gilliam, MD The University of Chicago Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Melissa Gilliam, Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT00653159     History of Changes
Other Study ID Numbers: 15498A
Study First Received: April 1, 2008
Results First Received: September 18, 2012
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Intrauterine device, contraception, unplanned pregnancy

Additional relevant MeSH terms:
Copper
Levonorgestrel
Medroxyprogesterone Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 21, 2014