Original Primary Outcome: Proportion of patients with no dysfunctional uterine bleeding symptoms during the 90-day reference period

Current Secondary Outcome:

• Proportion of Participants Cured From Prolonged Bleeding [ Time Frame: during a time period of 90 days under treatment ]
  Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.
• Proportion of Participants Cured From Frequent Bleeding [ Time Frame: during a time period of 90 days under treatment ]
  Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.
• Proportion of Participants Cured From Excessive Bleeding [ Time Frame: during a time period of 90 days under treatment ]
  Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.
• Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84 [ Time Frame: from baseline up to treatment day 84 ]
  The investigators assessed the participants' change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.
• Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196 [ Time Frame: from baseline up to treatment day 196 ]
  The investigators assessed the participants' change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.
• Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84 [ Time Frame: from baseline up to treatment day 84 ]
  Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.
• Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196 [ Time Frame: from baseline up to treatment day 196 ]
  Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.
• Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment [ Time Frame: Baseline and reference period of 90 days under treatment ]
  Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment.
• Menstrual Blood Loss Volume for All Participants at Cycle 1 [ Time Frame: 28 days ]
  Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle
• Menstrual Blood Loss Volume for All Participants at Cycle 3 [ Time Frame: 28 days ]
  Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles
• Menstrual Blood Loss Volume for All Participants at Cycle 7 [ Time Frame: 28 days ]
  Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles
• Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment
  
  

  Original Secondary Outcome: Proportion of patients cured from each individual symptom, such as excessive, frequent or prolonged bleeding.
  
  Information By: Bayer
  

  Dates:
  Date Received: March 27, 2006
  Date Started: February 2006
  Date Completion:
  Last Updated: November 5, 2013
  Last Verified: November 2013