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

Contraception Clinical Trial

— MINT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653159
• Other study ID #: 15498A
• Status: Completed
• Phase: Phase 4
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Levonorgestrel-releasing intrauterine device (LNG-IUS)
Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.
• Copper T380A intrauterine device (CuT380A)
Teens are randomly assigned to Copper T380 after the screening visit

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate	Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)	6 months
Secondary	Heavy Bleeding Rates	Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.	6 months
Secondary	Pregnancy Rates	Proportion of subjects who became pregnant within 6 months of IUD insertion	6 months
Secondary	Expulsion Rates	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.	6 months
Secondary	Device Satisfaction Rates	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.	6 months

External Links

•   University of Chicago Section of Family Planning and Contraceptive Research