Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial (MINT)
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ClinicalTrials.gov Identifier: NCT00653159 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Results First Posted : October 18, 2012
Last Update Posted : October 19, 2012
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Sponsor:
University of Chicago
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Melissa Gilliam, University of Chicago
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Tracking Information | ||||
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First Submitted Date ICMJE | April 1, 2008 | |||
First Posted Date ICMJE | April 4, 2008 | |||
Results First Submitted Date ICMJE | September 18, 2012 | |||
Results First Posted Date ICMJE | October 18, 2012 | |||
Last Update Posted Date | October 19, 2012 | |||
Study Start Date ICMJE | July 2007 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Retention Rate [ Time Frame: 6 months ] Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
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Original Primary Outcome Measures ICMJE |
Feasibility of screening, enrolling, randomizing, and retaining teens in a trial of dissimilar IUDs [ Time Frame: 6 months ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Contraception | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
23 | |||
Original Estimated Enrollment ICMJE |
24 | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Healthy, sexually active females age 14 to 18 who:
Exclusion Criteria: Sexually active females age over the age of 18 or who:
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Sex/Gender ICMJE |
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Ages ICMJE | 14 Years to 18 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00653159 | |||
Other Study ID Numbers ICMJE | 15498A | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Melissa Gilliam, University of Chicago | |||
Study Sponsor ICMJE | University of Chicago | |||
Collaborators ICMJE | University of Illinois at Chicago | |||
Investigators ICMJE |
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PRS Account | University of Chicago | |||
Verification Date | October 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |