Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial - Full Text View

Sponsor:	University of Chicago
Collaborator:	University of Illinois
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00653159

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Levonorgestrel

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Feasibility of screening, enrolling, randomizing, and retaining teens in a trial of dissimilar IUDs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bleeding patterns and rates of dysmenorrhea among teens randomized to the LNG-IUS or Copper T 380A. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Rates of expulsion and pregnancy for teens randomized to the LNG-IUS or Copper T 380A. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Quality of life among teens randomized to the LNG-IUS or Copper T 380A [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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	Device: Levonorgestrel-releasing intrauterine device (LNG-IUS) - Mirena IUD Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.
2: Active Comparator Paragard IUD	Device: Paraguard (Copper T380A) Teens are randomly assigned to Copper T380 after the screening visit

Eligibility

Ages Eligible for Study:	14 Years to 18 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653159

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
University of Illinois at Chicago
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

University of Chicago

University of Illinois

More Information

Additional Information:

University of Chicago Section of Family Planning and Contraceptive Research This link exits the ClinicalTrials.gov site

No publications provided

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Intrauterine device, contraception, unplanned pregnancy

Additional relevant MeSH terms:

Contraceptive Agents
Growth Substances
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Trace Elements
Copper

Reproductive Control Agents
Pharmacologic Actions
Levonorgestrel
Therapeutic Uses
Contraceptives, Oral, Synthetic
Micronutrients

ClinicalTrials.gov processed this record on November 27, 2009