MedTrace Logo

Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

NCT00528112 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2885

Last updated 2017-01-25

Study results available
· View outcomes & findings →

Summary

This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

Conditions

  • Contraception

Interventions

DRUG

LCS12

Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h

DRUG

LCS16

Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-07-31
Completion
2013-06-30

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Finland
  • France
  • Hungary
  • Mexico
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00528112 on ClinicalTrials.gov