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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

April 1, 2008
October 17, 2012
July 2007
December 2008   (final data collection date for primary outcome measure)
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)
Feasibility of screening, enrolling, randomizing, and retaining teens in a trial of dissimilar IUDs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00653159 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
 
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Contraception
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Female
14 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00653159
15498A
No
Melissa Gilliam, University of Chicago
University of Chicago
University of Illinois at Chicago
Principal Investigator: Melissa Gilliam, MD The University of Chicago Medicine
University of Chicago
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP