Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

• The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.
  
  
• Percentage of Patients With Successful Treatment [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.
  
  

• Percent Change From Baseline MBL to End of Study MBL (Cycle 6) [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.
  
  
• Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) [ Time Frame: Baseline and up to 3 months ] [ Designated as safety issue: No ]
  The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.
  
  
• Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) [ Time Frame: Baseline and up to 3 months ] [ Designated as safety issue: No ]
  The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.
  
  
• Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  
• Total Number of Bleeding Days [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
  
  
• Total Number of Spotting and Bleeding Days [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
  
  
• Total Number of Spotting Days [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
  
  
• Total Number of Bleeding Episodes [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
  
  
• Percent Change in Hemoglobin [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  
• Percent Change in Hematocrit [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  
• Percent Change in Serum Ferritin [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  
• Percentage of Patients With Improvement in the Investigator Global Assessment Scale [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  "Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'
  
  
• Percentage of Patients With Improvement in the Patients Overall Assessment Scale [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  "Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'.
  
  

Acronyms in the Adverse Event Section:

• IUCD Intrauterine Contraceptive Device
• MedDRA Medical Dictionary for Regulatory Activities

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer HealthCare AG, Germany.