Multi-center, Single-arm Study to Assess the Safety, Efficacy, Discontinuation Rate and Pharmacokinetics of the Low-dose Levonorgestrel Intrauterine Contraceptive System (LCS12) in Post-menarcheal Female Adolescents Under 18 Years of Age for 1 Year, and an Optional 2-year Extension Phase.

Trial Profile

Multi-center, Single-arm Study to Assess the Safety, Efficacy, Discontinuation Rate and Pharmacokinetics of the Low-dose Levonorgestrel Intrauterine Contraceptive System (LCS12) in Post-menarcheal Female Adolescents Under 18 Years of Age for 1 Year, and an Optional 2-year Extension Phase.

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2015

At a glance

  • Drugs Levonorgestrel (Primary)
  • Indications Pregnancy
  • Focus Adverse reactions; Registrational
  • Sponsors Bayer; Bayer HealthCare
  • Most Recent Events

    • 09 Jun 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov
    • 21 May 2015 Planned End Date changed from 1 Jun 2015 to 1 May 2015 as reported by ClinicalTrials.gov record.
    • 22 Oct 2014 Results presented at the 70th Annual Meeting of the American Society for Reproductive Medicine.
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