Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 microg/24h and 16 microg/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.
Phase of Trial: Phase III
Latest Information Update: 31 Jan 2017
At a glance
- Drugs Levonorgestrel (Primary)
- Indications Pregnancy
- Focus Registrational; Therapeutic Use
- Acronyms LCS Pearl Index Study
- Sponsors Bayer; Bayer HealthCare Pharmaceuticals
- 19 Sep 2016 According to a Bayer media release, based on the results of this trial, the US FDA granted marketing approval low dose levonorgestrel-releasing intrauterine system (LNG-IUS, Kyleena) for protection against pregnancy for up to 5 years.
- 20 Nov 2015 According to media release of Bayer HealthCare Pharmaceuticals, New Drug Application (NDA) is submitted to the U.S. Food and Drug Administration for approval for LCS-16 for pregnancy protection for up to five years.
- 14 Nov 2013 Results published in Obstetrics and Gynecology.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History