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Sponsors and Collaborators: |
University of Chicago University of Illinois |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | 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. 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.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Device: Levonorgestrel-releasing intrauterine device (LNG-IUS) - Mirena IUD Device: Paraguard (Copper T380A) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 24 |
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 |
---|---|
1: Active Comparator
Mirena IUD
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Device: Levonorgestrel-releasing intrauterine device (LNG-IUS) - Mirena IUD
Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.
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2: Active Comparator
Paragard IUD
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Device: Paraguard (Copper T380A)
Teens are randomly assigned to Copper T380 after the screening visit
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Ages Eligible for Study: | 14 Years to 18 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy, sexually active females age 14 to 18 who:
Exclusion Criteria:
Sexually active females age over the age of 18 or who:
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 |
Responsible Party: | University of Chicago ( Melissa Gilliam MD, MPH ) |
Study ID Numbers: | 15498A |
Study First Received: | April 1, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00653159 |
Health Authority: | United States: Institutional Review Board |
Intrauterine device, contraception, unplanned pregnancy |
Levonorgestrel Copper |
Contraceptive Agents Therapeutic Uses Growth Substances Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female |
Contraceptives, Oral, Synthetic Trace Elements Reproductive Control Agents Micronutrients Pharmacologic Actions |