NCT01539720

Brief Summary

The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

January 1, 2024

Enrollment Period

6 years

First QC Date

February 21, 2012

Results QC Date

September 3, 2023

Last Update Submit

January 28, 2024

Conditions

Pregnancy, UnplannedPregnancy; Accident

Keywords

emergency contraceptionEllaMirena IUDpost-coital contraceptionLiletta IUD

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Pregnancy Following Emergency Contraception

    Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group.

    5 weeks post-randomization

Secondary Outcomes (2)

  • Number of Participants Using Any LARC Method at 6 Months Post Randomization

    6 months post randomization

  • Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS

    6 months post randomization

Study Arms (2)

Levonorgestrel Intrauterine System

EXPERIMENTAL

Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following.

Device: levonorgestrel IUS

Ulipristal acetate

ACTIVE COMPARATOR

Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.

Drug: Ulipristal acetate

Interventions

Ulipristal acetateDRUG

30 mg tablet

Also known as: Ella
Ulipristal acetate
levonorgestrel IUSDEVICE

Levonorgestrel IUS, 52mg placed intrauterine

Also known as: Mirena IUD, Liletta
Levonorgestrel Intrauterine System

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women age 14-45
  • Under-protected intercourse within the last five days (120 hours)
  • Willingness to accept either intervention: intrauterine contraception or oral emergency contraception (EC)
  • Ability and willingness to follow-up for in clinic urine pregnancy test (UPT)
  • Ability and willingness to be contacted by phone for 6 and 12 month follow-up

You may not qualify if:

  • Positive pregnancy test
  • Non-English speaking
  • Contraindication to intrauterine contraception or oral EC
  • Inability or unwillingness to comply with follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Atlanta Women's Center

Atlanta, Georgia, 30342, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Interventions

ulipristal acetate

Limitations and Caveats

Group size limits the precision of our estimate.

Results Point of Contact

Title
Director of Research
Organization
Planned Parenthood of the St. Louis Region and Southwest Missouri
research@ppslr.org
314-531-7526

Study Officials

  • Colleen McNicholas, DO, MCSI

    Planned Parenthood of the St. Louis Region and Southwest Missouri

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

December 1, 2012

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

February 20, 2024

Results First Posted

February 20, 2024

Record last verified: 2024-01

Locations

US(3)