Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-05 @ 2:39 PM
Study NCT ID:
NCT00653159
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
Sponsor:
University of Chicago
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINT
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: