NCT00653159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

October 18, 2012

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

April 1, 2008

Results QC Date

September 18, 2012

Last Update Submit

February 21, 2023

Conditions

Contraception

Keywords

Intrauterine device, contraception, unplanned pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Heavy Bleeding Rates

    6 months

  • Pregnancy Rates

    6 months

  • Expulsion Rates

    6 months

  • Device Satisfaction Rates

    6 months

Study Arms (2)

Mirena IUD [LNG-IUS]

ACTIVE COMPARATOR

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)

Paragard IUD [Copper T380A]

ACTIVE COMPARATOR

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)

Interventions

Levonorgestrel-releasing intrauterine device (LNG-IUS)DEVICE

Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.

Also known as: Mirena IUD
Mirena IUD [LNG-IUS]
Copper T380A intrauterine device (CuT380A)DEVICE

Teens are randomly assigned to Copper T380 after the screening visit

Also known as: Paraguard IUD
Paragard IUD [Copper T380A]

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Results Point of Contact

Title
Dr. Sydeaka Watson, PhD
Organization
The University of Chicago Department of Health Studies, Biostatistics Laboratory
swatson@health.bsd.uchicago.edu
773-834-2378

Study Officials

  • Melissa Gilliam, MD

    The University of Chicago Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

July 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 23, 2023

Results First Posted

October 18, 2012

Record last verified: 2023-02

Locations

US(2)