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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Contraception	Device: Levonorgestrel-releasing intrauterine device (LNG-IUS); Device: Copper T380A intrauterine device (CuT380A)	Phase 4

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	23 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
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 Start Date :	July 2007
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	December 2008

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Mirena IUD [LNG-IUS]; Participants in this arm had a Levonorgestrel-releasing intrauterine device (LNG-IUS), also known as the Mirena IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.	Device: Levonorgestrel-releasing intrauterine device (LNG-IUS); Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.; Other Name: Mirena IUD
Active Comparator: Paragard IUD [Copper T380A]; Participants in this arm had a Copper T380A intrauterine device (CuT380A), also known as the Paragard IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.	Device: Copper T380A intrauterine device (CuT380A); Teens are randomly assigned to Copper T380 after the screening visit; Other Name: Paraguard IUD

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Retention Rate [ Time Frame: 6 months ]
   Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)

Secondary Outcome Measures :

1. Heavy Bleeding Rates [ Time Frame: 6 months ]
   Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
2. Pregnancy Rates [ Time Frame: 6 months ]
   Proportion of subjects who became pregnant within 6 months of IUD insertion
3. Expulsion Rates [ 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.
4. Device Satisfaction Rates [ 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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	14 Years to 18 Years (Child, Adult)
Sexes 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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Chicago

University of Illinois at Chicago

Investigators

Principal Investigator:	Melissa Gilliam, MD	The University of Chicago Medicine

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

University of Chicago Section of Family Planning and Contraceptive Research 

Responsible Party:	Melissa Gilliam, Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier:	NCT00653159 History of Changes
Other Study ID Numbers:	15498A
First Posted:	April 4, 2008
Results First Posted:	October 18, 2012
Last Update Posted:	October 19, 2012
Last Verified:	October 2012

Keywords provided by Melissa Gilliam, University of Chicago:

Intrauterine device, contraception, unplanned pregnancy

Additional relevant MeSH terms:

Levonorgestrel; Medroxyprogesterone; Medroxyprogesterone Acetate; Copper; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs	Contraceptives, Oral, Synthetic; Contraceptives, Oral; Trace Elements; Micronutrients; Growth Substances; Contraceptive Agents, Male; Antineoplastic Agents, Hormonal; Antineoplastic Agents