CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,885 enrolled
Drug / intervention
LCS12 +1 moredrug
Likely dose
Not stated in 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/NCT00528112
NCT00528112Phase 3Completed
CompareCT.gov

Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years

Bayer·interventional·Posted Sep 12, 2007·Updated Jan 25, 2017

In Brief

A Phase 3 clinical trial evaluating LCS12 and LCS16 for Contraception. Completed, enrolled 2,885 participants across 136 sites in 11 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesArgentina, Canada, Chile, Finland, France, Hungary, Mexico, Netherlands, Norway, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2007
Enrollment StartAug 1, 2007
Primary CompletionJul 1, 2011
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.8 years ago

Interventions

LCS12drug

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

LCS16drug

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