Levonorgestrel-releasing intrauterine device (LNG-IUS)
DeviceTeens are randomly assigned to receive the LNG-IUS after completing a screening visit.
Other names: Mirena IUD
NCT Number: NCT00653159
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.
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Notify Me14 year–18 year
Female
Interventional
Phase 4
University of Chicago, Chicago, Illinois, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy, sexually active females age 14 to 18 who:
Exclusion criteria
Sexually active females age over the age of 18 or who:
Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.
Other names: Mirena IUD
Teens are randomly assigned to Copper T380 after the screening visit
Other names: Paraguard IUD
Time frame: 6 months
Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
Time frame: 6 months
Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
Time frame: 6 months
Proportion of subjects who became pregnant within 6 months of IUD insertion
Time frame: 6 months
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.
Time frame: 6 months
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.
University of Chicago
Other
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
Acronym: MINT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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