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Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel-releasing intrauterine device (LNG-IUS) (Device); Copper T380A intrauterine device (CuT380A) (Device)

Phase: Phase 4

Status: Completed

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Melissa Gilliam, MD, Principal Investigator, Affiliation: The University of Chicago Medicine

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Retention Rate

Secondary outcome:

Heavy Bleeding Rates

Pregnancy Rates

Expulsion Rates

Device Satisfaction Rates

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.

Eligibility

Minimum age: 14 Years. Maximum age: 18 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

University of Chicago, Chicago, Illinois 60637, United States

University of Illinois at Chicago, Chicago, Illinois 60612, United States

Additional Information

University of Chicago Section of Family Planning and Contraceptive Research

Starting date: July 2007
Last updated: October 17, 2012

Page last updated: August 23, 2015

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