CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 274 enrolled
Drug / intervention
Ulipristal acetate +1 moredrug
Likely dose
Ulipristal acetate 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01539720
NCT01539720N/ACompleted

Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial

Planned Parenthood of the St. Louis Region and Southwest Missouri·interventional·Posted Feb 27, 2012·Updated Feb 20, 2024

In Brief

A clinical study evaluating Ulipristal acetate and levonorgestrel IUS for Pregnancy, Unplanned and Pregnancy; Accident. Completed, enrolled 274 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2012
Enrollment StartDec 1, 2012
Primary CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 14.3 years ago

Interventions

Ulipristal acetatedrug

30 mg tablet

levonorgestrel IUSdevice

Levonorgestrel IUS, 52mg placed intrauterine