Levonorgestrel Intrauterine System For Emergency Contraception

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.

Conditions

• Pregnancy, Unplanned
• Pregnancy; Accident

Interventions

DRUG

Ulipristal acetate

30 mg tablet

DEVICE

levonorgestrel IUS

Levonorgestrel IUS, 52mg placed intrauterine

Sponsors & Collaborators

• William and Flora Hewlett Foundation

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Planned Parenthood Federation of America

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Planned Parenthood of the St. Louis Region and Southwest Missouri

  lead OTHER

Principal Investigators

• Colleen McNicholas, DO, MCSI · Planned Parenthood of the St. Louis Region and Southwest Missouri

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2018-11-30

Completion

2018-11-30

Countries

• United States

Study Locations