Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)

• Pearl Index [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.
  
  

• Number of Subjects With Total or Partial Expulsions [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.
  
  
• Bleeding Pattern by 90-day Reference Periods - Reference Period 1 [ Time Frame: day 1 to day 90 ] [ Designated as safety issue: No ]
  Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
  
  
• Bleeding Pattern by 90-day Reference Periods - Reference Period 2 [ Time Frame: day 91 to day 180 ] [ Designated as safety issue: No ]
  Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
  
  
• Bleeding Pattern by 90-day Reference Periods - Reference Period 3 [ Time Frame: day 181 to day 270 ] [ Designated as safety issue: No ]
  Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
  
  
• Bleeding Pattern by 90-day Reference Periods - Reference Period 4 [ Time Frame: day 271 to day 360 ] [ Designated as safety issue: No ]
  Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
  
  
• Bleeding Pattern by 90-day Reference Periods - Reference Period 12 [ Time Frame: day 991 to day 1080 ] [ Designated as safety issue: No ]
  Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
  
  

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Although the title of the study describes "open", it was in fact single-blinded.

Issues on side effects are addressed in the Adverse Event section.